chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse and refers to 6 patients of unknown demographics. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored RECOMBIVAX HB strength reported as 2.5/0.5 (units not provided) (lot # L033343, expiration date: 13-SEP-2017; dose and route were not provided). The vaccine underwent a temperature excursion of 51.4 degrees Fahrenheit for 2 hours. Data logger was not involved and there was no previous temperature excursion. The vaccine storage was back in appropriate range. No adverse effects were reported. Additional information has been requested.
Injection area got real red immediately, then went away.  2 weeks later there was a pronounced magenta raised area a little larger than the size of a quarter.  The area was very tender.  After this went down, there was a bruise.
Pt recvd 3 doses of Hep B vax 28NOV89, 1JAN90, & 15MAY90 & 15SEP90 it was determined that titer was neg; booster dose was given 2OCT90 & outcome of booster dose is pending as of 3JAN92;
pt recv vax 2SEP94 & 3SEP94 pt exp swelling, redness & tenderness in deltoid area extending up into shoulder, devel a large nodule which was warm to touch @ the inj site; by 10SEP94 had completely recovered; No further details were provided
A healthcare professional reported the occurrence of injection site cellulitis in a 9-year-old male who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. The pt's medical history, concurrent conditions and concurrent medications were not reported. On 03/06/2003 the pt received an injection of Infanrix (lot DTPA568B9) which is not recommended for immunizing individuals 7 years of age or older. On 03/11/2003, 5 days post-immunization, he developed cellulitis at the injection site. He was seen by the physician on 03/13/2003. The reporter considered the injection site cellulitis to be probably related to Infanrix administration.
Child has had acidic and very watery stools since the evening of the immunization, which is unusual for him. No changes in diet prior or after immunization. Treating subsequent diaper rash with otc DESITIN cream.
Fever x 5 days. St. red bumps on tongue, vomiting. Rash started this AM 8/2/07
Adult dose given to pediatric client. No treatment, no adverse reaction noted. Medical director noted, no expected adverse reactions, no adverse reactions expected.
Body all broke out and itchy rash; itchy; rash flared up again today; fast heart beat; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (fast heart beat), RASH PRURITIC (Body all broke out and itchy rash), PRURITUS (itchy) and RASH (rash flared up again today) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis and Irritable bowel. Concomitant products included METHOTREXATE and DICYCLOVERINE HYDROCHLORIDE (BENTYL) for Irritable bowel, GOLIMUMAB (SIMPONI ARIA) for Rheumatoid arthritis.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PALPITATIONS (fast heart beat). On 29-Mar-2021, the patient experienced RASH PRURITIC (Body all broke out and itchy rash), PRURITUS (itchy) and RASH (rash flared up again today). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PALPITATIONS (fast heart beat), RASH PRURITIC (Body all broke out and itchy rash), PRURITUS (itchy) and RASH (rash flared up again today) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Blood pressure measurement: high (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was provided as steroid.
Vaccine was administered in drive thru clinic.  During the waiting period, she developed itching and was given Benadryl 50mg orally.  She did not develop hives or shortness of breath.  Symptoms resolved.  She was monitored after the event for extra period of time and then dismissed to home with instructions to monitor closely for any further symptoms and seek medical attention should these occur.
Arm pain around injection site. Worsened over time.  Given shot of NASID. Arm pain still persistent after 3 days. Respiratory difficulty. Cough suppressant and inhaler prescribed.
Information has been received from a physician concerning an 18 year old female with no medical history, who on 13-AUG-2007 was vaccinated with Gardasil.  Concomitant therapy given into the same arm included a dose of MENACTRA.  On 13-AUG-2007, the patient experienced pain and a knot in her arm.  Unspecified medical attention was sought.  No laboratory diagnostic studies were performed.  The patient's pain in arm and knot in arm persisted.  No product quality complaint was involved.  Additional information has been requested.
administered expired doses to patients past the published expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered expired doses to patients past the published expiration date) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered expired doses to patients past the published expiration date). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (administered expired doses to patients past the published expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.
I have had 3 Moderna Covid 19 Vaccinations. The 3rd was a full vaccine, not a 50% booster. Now 7 months after the 3rd vaccine my Doctor performed a test for SARS COV2 NUCLEOCAPSID ANTIBODIES and after 3 vaccines No Covid Antibodies! 5 of my family/friends that got the same vaccines and same antibody test at the same time had "High" Covid antibodies SARS COV2 TOTAL AB INTERPRETATION NEGATIVE SARS COV2 TOTAL AB INDEX 0.0 COI <1.0 COI
Injection site was itching.; This morning she had swelling at injection site; She had redness.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Injection site was itching.), VACCINATION SITE SWELLING (This morning she had swelling at injection site) and VACCINATION SITE ERYTHEMA (She had redness.) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Sep-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site was itching.), VACCINATION SITE SWELLING (This morning she had swelling at injection site) and VACCINATION SITE ERYTHEMA (She had redness.). At the time of the report, VACCINATION SITE PRURITUS (Injection site was itching.), VACCINATION SITE SWELLING (This morning she had swelling at injection site) and VACCINATION SITE ERYTHEMA (She had redness.) outcome was unknown.        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.   No concomitant medication details was reported. No treatment medication details was reported.
Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 81 years old female patient. Information regarding medical history, concurrent conditions, or concomitant medications was not provided. On or about 18-MAY-2010, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified), for the long-term prevention of shingles and zoster-related conditions.  On an unknown date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of shingles was unknown. The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).  Additional information has been requested.
Narrative:  Patient is a 84 year old male who presented to the emergency department 12/10/21 after experiencing including intermittent fever, chills, decreased appetite, generalized weakness. Testing revealed patient was positive for COVID19, lab results also showed hypomagnesemia, hyponatremia and AKI. Patient was admitted for observation and treatment. Patient has a past medical history of CKD, HTN, HLD, GERD, osteoporosis, bronchiectasis, prostate CA s/p XRT and COPD. Treatment included dexamethasone (12/11-12/16). Patient was discharged on 12/23 with supportive medications including albuterol, guaifenesin and benzonatate.
Large hard red mark at the injection site; Large hard red mark at the injection site; Flu like symptoms; Lightheaded; This case was reported by a nurse and described the occurrence of injection site erythema in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th January 2020, the patient received the 1st dose of Shingrix. On 7th January 2020, immediately after receiving Shingrix, the patient experienced injection site erythema, injection site induration, influenza-like symptoms and light headedness. On an unknown date, the outcome of the injection site erythema and injection site induration were unknown and the outcome of the influenza-like symptoms and light headedness were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site induration, influenza-like symptoms and light headedness to be related to Shingrix.  Additional details were provided as follows: The registered nurse reported case for herself. The patient stated that shortly after the Shingrix dose, she had flu like symptoms, along with lightheaded and had a large hard red mark at the injection site. The reporter consented to follow up. For tolerance after 2nd dose refer case US2020153365.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020153365:same reporter
arm was sore for two days; feels ill; kind of felt bad again/just didn't feel good; dizzy would come and go/still has dizzy spells; slept all day from 12:30-8; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore for two days), MALAISE (feels ill), FEELING ABNORMAL (kind of felt bad again/just didn't feel good), DIZZINESS (dizzy would come and go/still has dizzy spells) and HYPERSOMNIA (slept all day from 12:30-8) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was sore for two days), MALAISE (feels ill), FEELING ABNORMAL (kind of felt bad again/just didn't feel good), DIZZINESS (dizzy would come and go/still has dizzy spells) and HYPERSOMNIA (slept all day from 12:30-8). At the time of the report, PAIN IN EXTREMITY (arm was sore for two days), MALAISE (feels ill), FEELING ABNORMAL (kind of felt bad again/just didn't feel good), DIZZINESS (dizzy would come and go/still has dizzy spells) and HYPERSOMNIA (slept all day from 12:30-8) outcome was unknown. Not Provided          Concomitants - blood pressure and cholesterol medication Treatment -  Water, Gatorade Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) is considered as not applicable.
Patient reported feeling fatigue, chills, dry/puffy lips, bright red 3" red spot below the injection site that began 1-2 days after injection. Denies any difficulty breathing or shortness of breath.
had some dragging after the first dose; This is a spontaneous report from a contactable other-HCP (Patient)   A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685) on 23Dec2020 at single dose intramuscular in left deltoid  for COVID-19 immunization. The patient didn't have relevant medical history or concomitant drugs. Patient reported that she may have had some dragging after the first dose, but it was after the holidays and she was laying around anyway, so if she did, it was not of note to her at the time (as reported). At the time of the reporting event outcome was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021056967 same patient/drug, different event separated with time
DISCOVER VERTIGO KIND OF SYMPTOMS AS STANDING UP LOOSING MY BALANCE, NAUSEA, DIZZINESS, BLURRED VISION.
I had the shot and just getting over shingles / Suspected Vaccination Failure; getting over shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I had the shot and just getting over shingles / Suspected Vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: getting over shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was recovering/resolving.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 10-MAR-2023 This case was reported by a patient via interactive digital media. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.  The follow up would not possible as no contact details were available.
Rash and redness w/inflammation on the back of left back of arm. Increase temp and sensitive to the touch. He received ibuprofen and Triamcinolone Cream.
Technician administered vaccine according to standard protocol into patient's left deltoid. Patient has no allergies and was afebrile (96.7). Approximately  5 minutes post-vaccination patient's mother reported that the patient was feeling lightheaded, and shortly after the patient vomited. He stated he felt as though he had a fever coming on. The patient was given a bottle of water while EMS was called. EMS arrived to the scene shortly after the call and assessed the patient. Patient denied going to the hospital and left soon after. Patient reported to EMS that he was feeling anxious/nervous and this likely contributed to his adverse effects. No futher harm to patient.
Swollen, painful lymph node in left armpit 30hrs after vaccine; Swollen, painful lymph node in left armpit 30hrs after vaccine; This is a spontaneous report from a contactable nurse (patient). This 30-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN9581) via unspecified route of administration in the left arm on 05Feb2021 at 14:15 (at the age of 30-years-old) as a single dose for COVID-19 immunization. Medical history included allergy to sulfa from an unknown date and unknown if ongoing. The patient did not have COVID prior to vaccination. Concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number EL3246) in the left arm on 15Jan2021 at 14:00 (at the age of 30-years-old) for COVID-19 immunization. On 06Feb2021 at 20:00 the patient experienced swollen, painful lymph node in left armpit 30 hours after vaccine. No treatment was provided for the events. The clinical outcomes of swollen, painful lymph node in left armpit 30 hours after vaccine were unknown. It was also reported the patient had not been COVID tested post vaccination.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on vaccine administration date; A dose of 0.5ml of booster was administered; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on vaccine administration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on vaccine administration date), PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on vaccine administration date) and ACCIDENTAL OVERDOSE (A dose of 0.5ml of booster was administered) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2022 at 12:38 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. In December 2021, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on vaccine administration date). On 05-Feb-2022 at 12:38 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on vaccine administration date) and ACCIDENTAL OVERDOSE (A dose of 0.5ml of booster was administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on vaccine administration date), PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on vaccine administration date) and ACCIDENTAL OVERDOSE (A dose of 0.5ml of booster was administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  This vaccine was administered up until its manufacturer expiry date of 04-Apr-2022.  No treatment medication was reported.
1) Became light-headed, with a sensation of unawareness of my surroundings approximately 30 minutes after receiving the vaccine. I also experienced vertigo. 2) Within a week, I developed a rash on my face that was itchy and burned. It covered my cheeks. It worsened after each subsequent dose, until it was on my eyes and oozing by my third dose in August 2021.
Patient reported headache and weakness 1 day after vaccination and a large and hard red area on the back of arm the 2nd day after vaccination.
Patient had abnormally high Alkaline Phosphatase levels after receiving flu vaccine. Alkaline Phosphatase level was 5129 on 11/17/2017 and 3704 on 12/1/2017 (reference range for Alkaline Phosphatase is 130-317 IU/L).
Patient has a localized reaction consisting of a large 4 inch by 6 inch raised, itchy, red, and warm area at injection site. She says that over the past 5 days the redness has subsided but that the area is still raised and warm. Vaccine administrator counseled patient to keep monitoring her arm and to report any changes to her doctor.
Customer received vaccines at 12:15PM on the 17th, felt chills at 7PM, woke up with welts and red deltoid at 6:30AM on the 18th, now Dr. at 1PM, then got refer to ER right after where she was diagnosed with cellulitis and given IV, pain meds, and ABX.
Myalgia, low grade fever, fatigue, dry mouth, large local reaction 7 x 7 cm area warmth, induration and erythema - right deltoid region.
I was under the weather after getting the vaccine and now I have been diagnosed for having fluid around the heart.
In the evening of 21Aug2012 after Dtap was administered in the Left thigh child had edema, pain and erythema to left left where immunization was placed.  Area was from thigh to knee. The child came back to clinic and Benadryl RX was issued.  Child came back about 1 hour later and s/s had somewhat resolved better.
Headache, joint pain, muscle aches. None responded to aspirin or Aleve. Persists today.
took the flu shot, sickest had ever been in life; Initial information was received on 25-Nov-2021 regarding an unsolicited valid, social media, non-serious case received from another health professional.  This case involves a patient (unknown age and unknown gender, nurse for 20 years) who took the flu shot, sickest had ever been in life (illness) while receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number not reported, and expiry date not provided] via unknown route in unknown administration site for prophylactic vaccination.   On an unknown date the patient took the flu shot, sickest had ever been in life (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It is unknown if the patient experienced any additional symptoms/events.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on batch number for this case.
Pt recvd vax & stopped breathing, had an odd color, had vomit in mouth; MD stated findings of haemophilus influenzae in the blood culture also poss sepsis; final dx hematopoietic sys haemophilus influenzae sepsis, pulm edema, aspiration;
Information has been received through the Merck pregnancy registry, from a registered nurse concerning an approximately 18 year old female with no medical history of allergies who on 20-JAN-2008 was vaccinated intramuscularly with the first 0.5 mL dose of GARDASIL (Lot # 656373/0243U). Concomitant therapy included ADACEL and Tetanus Toxoid. Subsequently, it was reported that the patient is pregnant. The patient sought unspecified medical attention. Diagnostic laboratory testing included a urine pregnancy test. The due date was reported as 27-SEP-2008. At the time of this report the patient's outcome was unknown. No product quality complaint was involved. Follow up information was received from the initial reporter. She stated the patient transferred from their care due to preterm labor symptoms in July 2008. The patient had no further problems with preterm labor symptoms or any other concerns for the remainder of her pregnancy. She had an uncompleted vaginal birth on 25-SEP-2008 (reported as "25-SEP-2009") at 40 weeks gestation; there were no complications at the birth either. The baby had mild physiologic jaundice after delivery, which did not require treatment or an extended stay, and he was discharged home with his mother. The baby had met all of his developmental milestones and was healthy and well. Additional information has been requested.
Patient came to clinic on 01APR22 @0915 with complaints of arm tenderness. There was swelling, redness, and erythema on and around the injection site. She noticed the pain on 30MAR22 when she was changing. She has no fever (98.2) and no other symptoms. She spoke with the physician and went to see her primary healthcare provider.