chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Since vaccination he had 2 urine test that showed positive for alcohol in the urine / pee tests have been coming back positive for alcohol; This spontaneous case was reported by a consumer and describes the occurrence of URINE ABNORMALITY (Since vaccination he had 2 urine test that showed positive for alcohol in the urine / pee tests have been coming back positive for alcohol) in a 63-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 205E23A) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: Lisinopril 20mg (Taking, Lisinopril 20mg), Levothyroxine 25mg (Levothyroxine 25mg), Metoprolol, Lovastatin and HCTZ (HCTZ 25 mg). Past adverse reactions to the above products included No adverse event with HCTZ, Levothyroxine 25mg, Lisinopril 20mg, Lovastatin and Metoprolol. Concurrent medical conditions included Blood pressure high, Hypothyroidism and High cholesterol.    On 06-Oct-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On an unknown date, the patient experienced URINE ABNORMALITY (Since vaccination he had 2 urine test that showed positive for alcohol in the urine / pee tests have been coming back positive for alcohol). At the time of the report, URINE ABNORMALITY (Since vaccination he had 2 urine test that showed positive for alcohol in the urine / pee tests have been coming back positive for alcohol) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Urine alcohol test: (Positive) Since vaccination he had 2 urine test that showed positive for alcohol in the urine and (Positive) Since vaccination he had 2 urine test that showed positive for alcohol in the urine.     For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   He states that he had 2 DUI's about 10 months prior to vaccination. The court was making him to take classes and ransom unannounced urine alcohol tests. He states that he had Spikevax at local pharmacy on 06OCT2023. He states that he had been sober for 10 months now. He even got rid of his mouth wash and shaving cream because they had alcohol. He states that he does not had liver disease.  He had received 3 COVID-19 vaccine prior. Concomitant medications were not reported.  No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 13-Oct-2023: Live follow-up received include Reporter details added, suspect Product dose details updated, inarrative updated.
Report 2001028958-1 describes urticaria in a 14 year old female who received hep B vaccine recombinant (Engerix B). Medical history and concurrent conditions were not specified. She received no concurrent medications. On 7/31/01, the vaccinee received her second 10mcg injection of Engerix B. Within 24 hrs post-vaccination, she experienced urticaria. No medical attention was required. As of 12/4/01, she had recovered.
No additional adverse events reported.; Caller reports that a patient was administered an expired dose of GARDASIL 9 on 19Mar2023. Caller confirmed the dose expired on 15Mar2023; This spontaneous report was received from a nurse regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On 19-MAR-2023, the patient was vaccinated with a one expired dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (strength, frequency, route of administration, anatomical location and dose were not provided) (lot number W007026 has been verified to be a valid lot number for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast), expiration date reported as 15-MAR-2023, but upon internal validation was established as 04-DEC-2024) (expired product administered). It was confirmed by the reporter that the dose was properly stored up through the time of administration. No additional side effects were reported (no adverse event).
Immediately after recieving vaccination patient got light headed and sat down.  Patent vomitted and said was going to pass out.  We monitored blood pressure/HR and it was repeatedly between 130-150/110-125 with HR 115 to 130.  Patient stated her HR runs high and she had this happen once prior while giving blood.  After resting for about 30-45 minutes with ice packs on neck/head patient felt well enough to leave with husband.
Tested positive for COVID; Tested positive for COVID; This is a spontaneous report from a contactable consumer (patient) via a program.   A 13-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration at the left arm on 12Aug2021, at the age of 13 years old (Batch/lot number: EW0170) as single dose for covid-19 immunisation. Medical history included Seasonal allergy. The patient's concomitant medication included ZYRTEC. On unknown date the patient tested positive for Covid with outcome of unknown.  No follow-up attempts possible. No further information expected.
Initial misuse report received from a healthcare professional on 17 May 2013. MENOMUNE vaccine that out of storage condition, i.e. outside temperature 61-65 degree Fahrenheit for about 30 minute was administered to the patient (no information was provided regarding the patient). No adverse event was reported. Documents held by sender: none.
Initial report was received from an affiliate on 18 January 2011 (Key # 139115; ID 24999) who received the report from the patient's parent, who is also a health care professional. Additional information was received from the patient's parent on 25 January 2011. A two-year-old male patient had received a dose each of HIB, seasonal influenza and H1N1 influenza vaccines (manufacturers, lot numbers, routes, sites and dates of administration not reported) and a few hours after vaccination, the patient was able to talk, but could not associate words with their meaning. The patient's past medical history noted the patient had been breast fed for their first year of life and had far exceeded all milestones. The reporter stated they had been worried about vaccines and allergies with their son since birth and chose to follow an alternate vaccine schedule (two vaccines every two months instead of all at once). Between 16 and 18 months of age, the patient began to regress with language (severity not reported) and he developed OCD behaviors (described as organizing toys instead of playing with them). According to the reporter, at two years of age, the patient started talking again and was able to associate words with their meaning. An unspecified amount of time later, the patient received seasonal Influenza, H1N1 and HIB vaccines (dates not reported). A few hours post vaccination, the patient was able to talk, but could not associate words with their meaning. During the two weeks post vaccination, this continued and he regressed to just making noises. Two weeks after vaccination, the patient regressed to only humming. The patient's mother was "not sure if it was the HIB (vaccine), but definitely vaccine related". The patient was evaluated by specialists and had testing performed. He had multiple food allergies (eggs, dairy, soy and some vegetables - dates of onset not reported), his liver has decreased function to remove toxins (date of onset not reported) and he had heavy metal poisoning (specific metal not specified, date of onset not reported). Corrective treatments included chelation therapy, Probiotics due to yeast overgrowth, Glutathione (which results in some speech recovery, but speech then regressed again), N-Acetylcysteine, Multivitamins, fish oil, Vitamins A, C, D, E and K, and Methyl B12 shots (again resulting in some speech improvement at the time of the report). Outcome was not recovered. No additional information was provided at the time of the report. Documents held by sender: None.
pt recvd vax; hyporesponsive, shock rxn; brief apnea about 4-5 hrs p/vax; adm to hosp & will use monitor for a wk; anemia;
No adverse event; Patient received a 0.5ml dose of the monovalent Moderna COVID19 vaccine as a booster; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received a 0.5ml dose of the monovalent Moderna COVID19 vaccine as a booster) and NO ADVERSE EVENT (No adverse event) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS7165B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Oct-2022, the patient received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 22-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received a 0.5ml dose of the monovalent Moderna COVID19 vaccine as a booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received a 0.5ml dose of the monovalent Moderna COVID19 vaccine as a booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received a 0.5ml dose of the monovalent Moderna COVID19 vaccine as a booster).    No concomitant medications were reported.  No treatment information was provided.
After receiving her vaccine client stated that she feel a tingling sensation in the mid upper back area.  Vital signs obtained by EMS.  Bp 121/78, HR 82, O2 sat 97%, Blood sugar 120. Client states she feels better and discharged home by EMS.
- 1121: Patient reported being light headed.  Patient stated it might be because  of the excitement of getting the vaccine.  Patient has a history of hypertension,  arthritis (remission). Patient has a history of Bell's palsy and takes medication  for that. Patient stated normal B/P normally 130s/80s.
Received vaccines (PEDIARIX, PedVaxHib, PCV-13) 9:42am on 8-29-17. Developed swelling of Right leg, crying >2 hours. Treated with oral TYLENOL and hydroxyzine.
pt described rt arm swollen from the site of inj to right above elbow;pt described area as reddened or warm to touch;pt advised to see MD or to be seen in ER;
Pt states he got his second Covid vaccine yesterday.   Pt states he can hardly get his arm to the level of his chest.  He says his arm from his scapula to his elbow is swollen 2x the size.  He says around the injection site it is red, swollen, hard/firm and warm to touch.    Pt states he feels terrible, with nausea, sore throat, diarrhea, chills.  He says he is "breathing ok", but also has some "difficulty breathing".  He says his O2 sat is running 85 to 90% on RA.     His temp is 101.8 to 104.  His pulse is 100 to 104, RR 22 to 24, BP 140 to 160 over 100.
Patient had 2 doses of Moderna vaccine on 1/23/21, and 2/19/21, and was hospitalized for COVID resp failure on 3/7/22.  Patient remains hospitalized on 3/9/22
Following Moderna 2nd dose vaccine (lot # 045A21A) pt reported "throat swelling" and "face swelling" and "severe face, throat, and hand itching" at 2:52 PM. Pt was evaluated by, APN. Angioedema and posterior oropharynx edema was noted. Audible wheeze present. No hives visible. Vital signs: BP 100/60, HR 90, o2 90%. EMS called.   At 2:55 PM 0.3 mg of epi and 100 mg benadryl was administered IM.  3:00 PM  reevaluation revealed improvement in s/s. No additional epi was administered. Vitals also retaken: BP 130/80, HR 109, o2 99%.  3:05 EMS on scene and pt was transported to ED for evaluation/monitoring.  3:15 PM Dr. was notified of incident.  Pt reported w 1st Moderna vaccine she experienced "dizziness and heart racing" and "thought that was anxiety". She denied any respiratory distress, hives, edema, etc with that first dose. Allergies reported include oral sulfa drugs which she stated caused orbital edema.
Pt having difficulty breathing, hoarse voice, blotchy skin, 0.3 of Epinephrine given IM, O2 via nonrebreather, 95-100% SPO2 by 1 minute, recovering. Care given by Paramedic on site from Fire Dept.
Her husband translated for us. He said she was anxious before receiving this vaccine but then lightheaded after. On-site EMS responded. She vomited 10 minutes after EMS show up approximately 11:58 am. On-site physician said her heart rate was within normal limits, but no number was stated and her watch didn't detect anything. Note she did not have any problems with the first dose. She was released to home.
Severe Headache lasting for 12 hours. 12 hours post injection severe chills lasting for 3 hours. Metallic taste in mouth lasting 1 hour.
pt completed a Hep B vax series in 1991; 4JAN92 testing showed hepatomegaly; subsequent testing on 20MAY92 revealed cirrhosis;
administration date: 28May2021, dose number: 2/prev dose administration date=14May2021, prev dose dose number: 1; A week after I got the shot 1 morning I just couldn't catch my breathe and it's been since 2021 it's now 2 years later and I still can't breathe right; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 21-year-old male patient received BNT162b2 on 28May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 21 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Other medical history: Asthma; "Known allergies: Food which includes shellfish" (unspecified if ongoing), notes: Known allergies: Food which includes shellfish and most fruits; "Known allergies: most fruits" (unspecified if ongoing), notes: Known allergies: Food which includes shellfish and most fruits. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Right), administration date: 14May2021, when the patient was 21-year-old, for COVID-19 immunization. The following information was reported: RESPIRATION ABNORMAL (non-serious) with onset May2021, outcome "not recovered", described as "A week after I got the shot 1 morning I just couldn't catch my breathe and it's been since 2021 it's now 2 years later and I still can't breathe right"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 28May2021, outcome "unknown", described as "administration date: 28May2021, dose number: 2/prev dose administration date=14May2021, prev dose dose number: 1". Therapeutic measures were taken as a result of respiration abnormal.  Additional information: Patient not had covid prior vaccination. Patient tested covis post vaccination. Patient not had any other vaccine in four weeks. A week after patient got the shot 1 morning and he just couldn't catch his breathe and it's been since 2021 it's now 2 years later and he still could not breathe right. AE treatment includes many asthma relieves/steroids/oxygen.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
- Pt reports immediate fussinesss, irritable, with no energy (around 10 am after injection)  - After dinner felt fatigued, stomach rumbling/hurting - Felt nauseous with a headache and a low grade fever < 100 F overnight. - The next morning pt reported arm swelling with a large white outline the size of her palm, lower than where injection site was.
Information has been received from a registered nurse concerning a patient who on 22-MAY-2007 was vaccinate with a 0.5mL subcutaneous dose of varicella virus vaccine live (Oka/Merck) (lot # 657191/0365U). The patient developed erythema and swelling at the injection site 5 minutes after administration of the vaccine. No therapy was recommended. There were no laboratory or diagnostic tests performed. The outcome is unknown. No further information was available at the time of this report. Unspecified medical attention was sought. No product quality complaint was involved. This is patient 2 of 2. Additional information has been requested.
The muscle under armpit is swollen in injection arm; Feeling bad; Bad headache, did not do much at all; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling bad), HEADACHE (Bad headache, did not do much at all) and LYMPHADENOPATHY (The muscle under armpit is swollen in injection arm) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067F21A, 058K20A and 026L20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), METFORMIN and ACYCLOVIR [ACICLOVIR] for an unknown indication.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Dec-2021, the patient experienced FEELING ABNORMAL (Feeling bad) and HEADACHE (Bad headache, did not do much at all). On 19-Dec-2021, the patient experienced LYMPHADENOPATHY (The muscle under armpit is swollen in injection arm). At the time of the report, FEELING ABNORMAL (Feeling bad), HEADACHE (Bad headache, did not do much at all) and LYMPHADENOPATHY (The muscle under armpit is swollen in injection arm) outcome was unknown.            No medical history was provided by the reporter.   The patient stated that on 18-Dec-2021, the patient was feeling bad and had a bad headache and did not do much at all. On 19-Dec-2021 morning, the muscle under armpit was swollen in injection arm.  No treatment information was provided.
Pneumovax left deltoid IM then swelling at site began within a few hours. Fever the next day and now temperatures measuring normal since 6/10/07 (last fever) but still chills this am. Redness now extends toward elbow but is less red. Does itch some. No axillary lymphadenopathy. Using antihistamines.
Difficulty breathing, throat swelling.  Called 911 and treated with EpiPen at 2:45PM.  Patient was improving and was taken by EMS to local hospital for further treatment/monitoring.  We attempted to contact the patient on 1/19 and 1/20 but did not receive a return call.
Itchy, blotchy red rash around injection site on arm. I noticed it approximately one week after getting my first Moderna shot
On 7/11/00, the pt complained of right hip pain. On 8/31/00, the pt complained of left hip pain. He also had migratory pains and swellings in hands, elbows, and knees. He was referred to an orthopedic surgeon.
This spontaneous report was received from a nurse practitioner (N.P.) concerning a 15 year old female patient. The patient had no pertinent concurrent conditions, medical history or drug reactions. On 21-JUN-2015, the patient was vaccinated with the first dose of GARDASIL 9 intramuscular as well as a dose of VAQTA, both in the left deltoid (dose and Lot No. were not reported). On 10-AUG-2015, the patient came back to the office complaining of a mass at the injection site of the VAQTA and GARDASIL 9. The nurse described the mass as grape in size in the upper deltoid and deeper than subcutaneous tissue. The patient was directed to see a surgeon, who stated that this was a vaccine related reaction and patient was prescribed an unspecified antibiotic as treatment. The reporter does not know if this patient has had resolution yet, because she has not heard nothing from the surgeon nor the patient. No laboratories studies were performed. No Product Quality Complaint (PQC) was involved. The outcome of vaccination site reaction was unknown. The reporter considered vaccination site reaction to be related to GARDASIL 9 and VAQTA. This is one of several reports from the same source. Additional information has been requested.
Swollen lymph node on injected site started 5 days after injection Area from injection site getting red, swelling, and pain 7 days after injection
Hospital Course: #1 confusion versus side effect from moderna Covid vaccine versus transient global amnesia Patient is a 60-year-old female with past medical history of traumatic brain injury 1985 was in coma for 2 weeks, hypothyroidism who had Moderna vaccine for COVID-19 5 days prior to admission, patient had some weird symptoms are multiple symptoms over the weekend yesterday she ended up going to the work without eating breakfast and was found to be confused. Patient works as a supervisor and an aide at high school was brought in by ambulance for confusion.  Patient did have low blood sugar and I feel like 40 but she had an eating her breakfast.  She was given D50 and brought to Hospital ER. Patient had no neurological side effects by the time she came to the ER she was already recovering. Patient's work-up was unremarkable including CT head and neck angio, MRI brain, echocardiogram. She was hospitalized on the stroke pathway.  She had no arrhythmia, no further signs and symptoms of stroke, as mentioned above her cardiac and stroke work-up was all negative.   Patient does have hyperlipidemia and she was started on atorvastatin.   Patient symptoms had started 8:00 on the day of admission and resolved after 4 to 5 hours.  She had no neurological deficits so she was not a candidate for TPA.   Patient is doing good today her confusion has completely resolved.   Patient is discharged on aspirin and Lipitor.  #2 hypothyroidism Continue  Synthroid, her thyroid panel was normal.   #3 hypoglycemia Cortisol level is normal, and explainable hypoglycemia but she had not eaten the day prior to going to work and on the morning of admission.  She has recovered nicely and no further hypoglycemia was noted in the hospital.   #4 recent COVID-19 vaccine by Moderna Patient had reaction 5 days prior to admission it could be that she had side effects possible but not clear.   #5 hyperlipidemia Patient's cholesterol is 253, LDL is 179, HDL is 57 triglycerides are 86.  She is started on Lipitor 40 mg a day.  She should diet and exercise and repeat lipid panel to be done in 3 months.
Approximately 4 days after vaccine a large red area appeared around the injection site.  It was about the size of large lemon.  It was warm but not hot to the touch.  The initial reaction to the vaccine was redness about the size of a silver dollar, warm and tender for about 24 hours and then resolved.  The second occurrence was 4 days after the vaccine. We used ice packs and advil but the next day it was larger and redder and by 48 hours later it was quadrupled in size - roughly 8" x5".  On  Friday afternoon 01/15/2021, we held a telemed conference with her internist.  She prescribed methylprednisolone 4mg dosepack for a total of 6 days beginning 01/16/2021, she also prescribed 7 days of 3x/day Cephalexin 500 mg, and Triamcinolone .1% cream.  She also recommended hot then cold alternating packs on the affected area and  using Tylenol or Ibuprofen several times a day.   On todays date 01/17/2021 the redness has faded probably 30 - 50% and it's size has shrunk 20% as well.   I observed my wife getting her vaccine from a nurse (I have no name) and although I could be wrong it was my impression she cotton swabbed with alcohol on  an upper a smallish area on the left arm (size of a quarter), but proceeded to give the injection just above the swabbed area ?..
Severe muscle spasms (requiring a muscle relaxer); low grade fever (99.3) and chills.
After sitting for the required 15 minutes, stood up and felt light headed and fuzzy. Waited for it to pass and walked to car.  Sat in car for a few minutes,  drank some water and had a few bites of a protein bar.  Felt hot,  flushed, broke out in an all over sweat.  Waited about 5 minutes, continued to sip water and nibble on protein bar.  It eventually passed.   On and off headache for next couple of hours.  Only some injection sight tenderness since then.