chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a licensed visiting nurse concerning a 25 year old female patient with no pertinent medical history or drug reaction and allergies, who on 11-APR-2008 was vaccinated with the first dose of GARDASIL (Lot # 654490/0133X), (route no reported), on 10-JUN-2008 the patient received the second dose of GARDASIL (Lot # 654490/0122X), (route no reported), and on 07-OCT-2008 was vaccinated with the third dose of GARDASIL (Lot # 659184/0843X) (route no reported). Concomitant therapy included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufactured unknown). The nurse reported that on an unspecified date, the patient tested positive for HPV and developed atypical squamous undetermined origin. At the time of the report, the patient had not recovered. The patient sought unspecified medical attention. A PAP smear and HPV DNA test were performed. Follow-up information has been received from a licensed visiting nurse and medical records concerning a 25 year old female patient who on 11-Apr-2008 was vaccinated with the first dose of GARDASIL (Lot # 664490/0133X), left deltoid-IM, on 10-JUN-2008 the patient received the second dose of GARDASIL (Lot # 654490/0133X), right deltoid-IM, and on 07-OCT-2008 was vaccinated with the third dose of GARDASIL (Lot # 659194/0843X) right deltoid-IM. On 20-AUG-2010, the patient's routine PAP showed HPV detected and developed atypical squamous cells undetermined significance. On 30-AUG-2010, the patient's HPV DNA pathology report showed HPV DNA detected, reference range was not detected, general categorization: epithelial cell abnormality and the interpretation and result were atypical squamous cells of undetermined significance. The patient's clinical information listed, intrauterine contraceptive device, last menstrual period 10-AUG-2010 and a previous PAP test in Mar-2009 (no results provided). On 20-OCT-2010 repeat PAP showed atypical squamous cells of undetermined significance. Note stated patient could repeat in three months or undergo colposcopy. On 06-DEC-2010, the repeat PAP and tissue pathology revealed diagnoses of endocervix curettage (benign endocervical mucosa) and cervix biopsy (benign reactive exocervical mucosa and transition zone and endocervix not present). The patient's outcome was not provided. All available medical records will be provide upon request. Additional information has been requested.
Case was hospitalized for covid 7 months after completion of vaccination series.  * Pneumonia due to COVID-19 virus Assessment & Plan Symptom onset about 13 days ago with positive COVID-19 test 6 days prior to admission. Fully vaccinated February-March with Pfizer vaccine, but notable that she is on immune suppressive therapy for her renal transplant. CXR on admission consistent with viral pneumonia. Only mild hypoxia on 2L/min nasal cannula on admission. Outside time window for Remdesivir, and her renal function would preclude this in any case. - dexamethasone 6mg daily. - continue supplemental oxygen as needed. -not needing supplemental O2 at discharge. Gave return precautions.
This is a spontaneous report from a contactable physician (patient). A 57-year-old female patient received the second dose of BNT162B2 (lot number: EL1283), via an unspecified route of administration in left arm on 06Jan2021 14:00 at single dose for covid-19 immunization. The patient's known allergies: latex (rash, occ. mild bronchospasm); dysphoria c valium; innumerable food reactions - dairy & eggs, nuts/seeds/grains, fish, latex associated foods, nightshades, meat -but none anaphylactic (occ. debilitating headache, very occ. mild bronchospasm; mostly cholinergic urticaria / joint pain / diarrhea). Other medical history included atopic incl. Raynauds; parox. atrial tach (after ablation for PA-fib.); almost-asx'tic asthma; endometriosis c small bowel resection (terminal ileum). Concomitant medication included metoprolol and a very long list of supplements. The patient previously received the first dose of BNT162B2 (lot number: EH9899), at the age of 57-year-old, via an unspecified route of administration in left arm on 18Dec2020 10:00 at single dose for covid-19 immunization and experienced deltoid soreness. The patient experienced trivial deltoid soreness for maybe 36 h after injection, starting about 4-6h later (06Jan2021) (same as after 1st injection, tho maybe lasted a bit longer); not sore enough to limit her use of the arm even a little bit. However, post injection day #4 (10Jan2021) after mod. intense workout for 2nd day in a row (swimming 1mi, including butterfly & synchro; usu. She wait 1-2 days between workouts) She developed a mod./severe headache, joint aches and malaise. She neglected to take a temp; and interestingly the injection site got sore again. This lasted about 48h; fortunately she was not scheduled to work. No sx since then, 1week. No treatment received. No pregnant. The outcome of the events was recovered on Jan2021.
Patient was administered 0.3ml of improperly prepared vaccine.   I mixed 0.8ml of diluent instead of 1.8ml.  The patient then was administered 0.3ml.  This was realized at 2:30 pm.  9/13/2021- I spoke with the patient's mom to see how she did with post vaccination.  Mom stated, "she has done fine, her arm was just a little sore when she lifted it, which is normal, other than that she's good".  I informed mom on the vaccine volume administration.  Mom stated she understood and was okay with the outcome.  According to CDC's Pfizer guidance, no repeated doses needed.
5 minutes after administration, arms and legs went rigid; arms/hands turned inward at center of body; head stiff and turned to left shoulder; no response to verbal/tactile stimuli; lasted 30-40 seconds.  Then began talking and was oriented to person, place, and time; sweating.
MORNING AFTER VACCINE, DEVELOPED CHILLS, BODY ACHES, HEADACHE, NAUSEA, AND RASPY VOICE.
Same day, pt had heart palpitations, SOB, HA, dizziness. Later that night, pt had perfuse vomiting, migraine, faintness, weakness, diarrhea and right arm tingling/numbness.
terrible sleep; cold sweat / still feeling cold sweat; been feeling really bad; dizziness; rash on the stomach; fatigue; chills; heart beats too fast; legs are purple and under the left feet; blurry vision; This spontaneous case was reported by a patient and describes the occurrence of SOMNOLENCE (terrible sleep), VISION BLURRED (blurry vision), COLD SWEAT (cold sweat / still feeling cold sweat), HEART RATE INCREASED (heart beats too fast) and SKIN DISCOLOURATION (legs are purple and under the left feet) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, the patient experienced VISION BLURRED (blurry vision). On an unknown date, the patient experienced SOMNOLENCE (terrible sleep), COLD SWEAT (cold sweat / still feeling cold sweat), HEART RATE INCREASED (heart beats too fast), SKIN DISCOLOURATION (legs are purple and under the left feet), MALAISE (been feeling really bad), DIZZINESS (dizziness), RASH (rash on the stomach), CHILLS (chills) and FATIGUE (fatigue). The patient was treated with ACETYLSALICYLIC ACID (BABY ASPIRIN) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (terrible sleep), VISION BLURRED (blurry vision), COLD SWEAT (cold sweat / still feeling cold sweat), SKIN DISCOLOURATION (legs are purple and under the left feet), MALAISE (been feeling really bad), DIZZINESS (dizziness), RASH (rash on the stomach) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: (High) Heart rate increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medicine include Acetaminophen, Baby Aspirin, Water Action taken with mRNA-1273 in response to the event was unknown     Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: significant doc received on 03-JUN-2021, additional events Heartbeats too fast, Fatigue, chills, and legs are purple, and under the left feet were added
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. The nurse provided that in May 2016, she had a temperature excursion (to 34. 4 for 8 hours and 24 minutes) with PNEUMOVAX 23 (lot # L019836 with expiration date 24-MAR-2017). On unknown dates in 2016, the patients were administered the improperly stored doses of PNEUMOVAX 23 (dose and route were not reported). On an unknown date in 2016, the vaccines had a second excursion to 28.9F for 8 hours cycling every 20 minutes. No vaccines were administered since the second excursion. This is one of several reports received from the same reporter. Additional information has been requested.
Headache, Diarrhea, NauseaVomiting, Fatigue, Pain, Chills Narrative:
Mother received the vaccine on 10/26/20 and had a series of issues that resulted in hospitalizations, but finally diagnosed with "suspected" viral meningitis/encephalitis. Diagnosed with pneumonia and UTI on 10/29, released on 10/31 with dementia symptoms attributed to UTI. However, rushed back to hospital 11/1 unconscious, shivering, seizing, sweating. rushed to ICU @  Hospital where neurological symptoms became serious, including brain seizures that would not subside. Induced into a medical coma to ease . Lumbar punctures show no bacterial or viral evidence. Autoimmune suspected as well but no real diagnosis as of yet. She remains in a minimally conscious state as a result of the neurological stresses that remain undiagnosed.
Woke up the day after the vaccine with a fever that started at 99 but increased to 102, chills, headache, aches, inability to go to work. These side effects lasted one whole day after the vaccine.
Broke out in rash from lower extremities to thighs, looks like measles rash, slightly raised, red and itchy
Pain; Redness; Swelling; Itching; Rash; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 41-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EL9262 and expiration date was not reported), via an unspecified route of administration, administered in Left Arm on 27Jan2021 (Age at vaccination was 41 years) as dose 1, single for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date in 2021, the patient developed redness, swelling, patient was not able to work the next day due to the pain. Pain at the injection site on the left arm. The pain was unreal. Pain probably lasted for two days. Redness and rash developed later on, probably five to six days after the injection. Patient was not in contact with anything. The rash has gone away, but he still has crazy itching. The outcome of events pain, redness, swelling was unknown and not recovered for itching. Patient was recovered from rash on unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.
Ranging in the ears...I had thought and hoped it would go away by now and it hasn?t, so just felt I should report it.  I have never experienced this prior to vaccine.
Chills; muscle and joint aches; muscle and joint aches; weakness; vomiting; headache; fever 99.5; arm pain; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 27Apr2021 at 13:00 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis, hypothyroidism, blood pressure high, high cholesterol, (unspecified) allergies, COVID-19 and allergy to sulfa drugs and latex. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), hydroxychloroquine (MANUFACTURER UNKNOWN) and leflunomide (MANUFACTURER UNKNOWN); all from unknown date for unknown indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Apr2021 at 10:00, the patient experienced chills, muscle and joint aches, weakness, vomiting, headache, fever 99.5 and arm pain. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, muscle and joint aches, weakness, vomiting, headache, fever 99.5 and arm pain was not recovered at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a child male patient who received INFANRIX. Co-suspect products included BOOSTRIX. On an unknown date, the patient received INFANRIX at an unknown dose and BOOSTRIX at an unknown dose. On an unknown date, an unknown time after receiving INFANRIX and not applicable after receiving BOOSTRIX, the patient experienced allergic reaction and circumstance or information capable of leading to medication error. On an unknown date, the outcome of the allergic reaction and circumstance or information capable of leading to medication error were unknown. It was unknown if the reporter considered the allergic reaction to be related to INFANRIX. Additional details were provided as follows: This case was reported by the patient's grandmother. The patient had experienced an allergic reaction after vaccination with INFANRIX when he was a baby. The reporter stated that the patient was allergic to something in the vaccine. She also added that he is allergic to a certain food but could not recall the name. At the time of reporting, the patient was 7 years old and was prescribed BOOSTRIX vaccine in order to attend school, which led to circumstance or information capable of leading to medication error. The reporter initially inquired about ingredient because she could not locate them in the Product Information (PI). The reporter declined to provide additional information like address and adverse event information as she did not have the time.
Hives; This is a spontaneous report from contactable nurse via a Pfizer sales representative. A 17 1/2-year-old female patient received the first dose of meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced hives on an unspecified date. Event took place after use of product. The outcome of the event was unknown.   No follow-up attempts are possible. No further information is expected.
Hot and cold flash fever off and on Cough  Muscle or body aches  Headache Acute hypoxemic respiratory failure   Pneumonia due to COVID-19 virus  Received plasma therapy remdesivir  dexamethasone?changed to oral Decadron upon discharge
Bloody Diarrhea; gastrointestinal issues; This case was reported by a physician via call center representative and described the occurrence of bloody diarrhea in a 2-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number FX2TZ, expiry date 5th September 2021) for prophylaxis.   On 16th September 2020, the patient received the 1st dose of Rotarix lyophilized formulation (oral). On 30th September 2020, 14 days after receiving Rotarix lyophilized formulation, the patient experienced bloody diarrhea (serious criteria GSK medically significant) and gastrointestinal disorder. On an unknown date, the outcome of the bloody diarrhea and gastrointestinal disorder were recovering/resolving.   It was unknown if the reporter considered the bloody diarrhea and gastrointestinal disorder to be related to Rotarix lyophilized formulation.  Additional case details were reported as follows: The reporter inquired about the incidence of bloody diarrhea in a two month old patient that was given an oral dose of Rotarix. Two weeks later on 30th September 2020, patient started with gastrointestinal issues that on 1st October 2020, developed to bloody diarrhea. No other symptom was confirmed for the patient. The reporter consented to follow up. As per sales data sheet reported batch number was changed from  FX2TZ9521 to FX2TZ.. The gastrointestinal issues was considered as sign and symptoms of bloody diarrhea, and therefore accordingly event onset date was captured as 30 Sep 2020.
Balance was way off-hit right shoulder and left shoulder walking into bathroom with very narrow hallway.  VERY very dizzy.  Went back to bed and slept from 6am-1:30 pm. Felt better 24 hours later.
ROUND DIME SIZE LUMP ADJACENT TO INJECTION SITE. APPEARED SHORTLY DAYS AFTER REC. INJECTION
Patient received the 1st COVID vaccine Pfizer Lot#EW0185 on 05/22/21 at 11:18AM. The patient presents to the vaccination site today for her 2nd COVID Pfizer vaccine with her mother. She alerted RN that she developed dizziness 24 hours following her 1st vaccine. RN alerted RN lead who responded. The patient told RN the dizziness lasted about one hour. She did eat prior to receiving the vaccine on 05/22/21. The patient did eat today prior to presenting to the vaccination site. The patient did not report SOB after the 1st dose of COVID vaccine Pfizer. The patient did not consume any medications for the reactions to the 1st dose. They did not follow up with any medical care providers after developing dizziness. The patient denies any chronic conditions, or current medications. The patient has no known allergies. RN consulted with the Medical Consult Team regarding the patient and her reactions to the first dose of COVID vaccine Pfizer. Approval was received from PHN via text message. RN provided education regarding s/s of anaphylaxis, to report any symptoms during observation to EMT, to follow up with PCP if the patient develops any symptoms post vaccination, to consume water prior to vaccination and after, and V-safe. The patient was also instructed to wait 30 minutes in the observation period. The patient and her mother voiced understanding of this. The patient stated she had already drank water while waiting in line pending vaccination. Patient received the 2nd COVID vaccine Pfizer Lot#EW0187 on 06/12/21 at 12:44PM. The patient waited in the observation area for 30 minutes with her mother. She did not alert the EMTs of any symptoms during her observation period.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (Usual discomfort at injection site), RASH PRURITIC (Itchy rash on left arm), RASH ERYTHEMATOUS ((Itchy) red rash on left arm), VACCINATION SITE RASH (Rash at the site of the injection in left arm) and VACCINATION SITE PAIN (soreness at the site of the injection in left arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Medical history was not provided by the reporter.  Concomitant products included AMLODIPINE, LOSARTAN, HYDROCHLOROTHIAZIDE, LEVOTHYROXINE, ACYCLOVIR [ACICLOVIR], SALBUTAMOL (VENTOLIN [SALBUTAMOL]) and AZELASTINE HYDROCHLORIDE (ASTELIN [AZELASTINE HYDROCHLORIDE]) for an unknown indication. On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced VACCINATION SITE RASH (Rash at the site of the injection in left arm), VACCINATION SITE PAIN (soreness at the site of the injection in left arm), VACCINATION SITE PRURITUS (itching at the site of the injection in left arm) and VACCINATION SITE ERYTHEMA (redness at the site of the injection in left arm). On 23-Feb-2021, the patient experienced VACCINATION SITE DISCOMFORT (Usual discomfort at injection site), RASH PRURITIC (Itchy rash on left arm) and RASH ERYTHEMATOUS ((Itchy) red rash on left arm). In February 2021, VACCINATION SITE RASH (Rash at the site of the injection in left arm), VACCINATION SITE PAIN (soreness at the site of the injection in left arm), VACCINATION SITE PRURITUS (itching at the site of the injection in left arm) and VACCINATION SITE ERYTHEMA (redness at the site of the injection in left arm) had resolved. At the time of the report, VACCINATION SITE DISCOMFORT (Usual discomfort at injection site), RASH PRURITIC (Itchy rash on left arm) and RASH ERYTHEMATOUS ((Itchy) red rash on left arm) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. Treatment medications were not used by the patient. This case was linked to MOD-2021-244825. Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Additional events: Vaccination site discomfort, Rash pruritic, Rash erythematous.
pt recv vax 15AUG97 & 17AUG97 pt exp sweating, lightheadedness & loss of balance;19AUG97 pt seen by MD dx w/mild rxn to vax;
Swelling at injection site a few hours after injection. The next day (02/10/2017) patients entire arm was swollen and pain in the joints. Patient in today (02/16/2017) with redness, warmth, and swelling in the hand of the arm he received the immunization in. Treated with Solu-Medrol injection and Keflex.
Dizziness; Weakness; Disoriented; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), ASTHENIA (Weakness) and CONFUSIONAL STATE (Disoriented) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No medical history reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced DIZZINESS (Dizziness), ASTHENIA (Weakness) and CONFUSIONAL STATE (Disoriented). At the time of the report, DIZZINESS (Dizziness), ASTHENIA (Weakness) and CONFUSIONAL STATE (Disoriented) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant medication was not reported.  Treatment information was not reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
At site of injection - large slightly raised pink area 25mm x 25mm - warm to touch c/o of pain in shoulder & upper arm. Tx - ice pk and ibuprofen 400mg q 3- 4 hours for pain & inflammation.