chrisvoncsefalvay/vaers-outcomes huggingface dataset:
That night after my son's shot around 12:00 AM, my son had a stare on his face. I picked him up and he wasn't breathing, he was drooling. I got him to breathe and was taking him to the hospital and his eyes went up and his head fell to one side. No seizure. Temperature was 102.8 at the hospital. Discharge Summary received stated that patient experienced elevated WBC and bronchiolitis.
Swollen, semi-itchy, painful, and red injection site; Swollen, semi-itchy, painful, and red injection site; Swollen, semi-itchy, painful, and red injection site; Swollen, semi-itchy, painful, and red injection site; its is warm; Neared a fever; This is a spontaneous report from a contactable consumer, the patient. A 21-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 09Apr2021 at 13:45 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and heart arrhythmia. The patient did not have any allergies to food, medications, or other products. Concomitant medications included levonorgestrel (LILETTA) Intrauterine Device (IUD), iron (MANUFACTURER UNKNOWN) and ascorbic acid (VITAMIN C), all taken for unspecified indications from unknown dates. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 19Mar2021 at 14:45 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other medications or vaccines within 4 weeks prior to the vaccination. On 10Apr2021 at 09:00, the patient experienced swollen, semi-itchy, painful and red at injection site and had a knot/bump on it and was warm and painful to touch. It had slowly gotten bigger every day since receiving the vaccine and the patient neared a fever the day after receiving the vaccine. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events swollen, semi-itchy, painful and red at injection site with a knot/bump, warm and painful to touch and fever were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
bruises easily; COVID booster vaccine caused itchiness and bruising; COVID booster vaccine caused itchiness and bruising; This spontaneous case was reported by a consumer and describes the occurrence of INCREASED TENDENCY TO BRUISE (bruises easily), VACCINATION SITE BRUISING (COVID booster vaccine caused itchiness and bruising) and VACCINATION SITE PRURITUS (COVID booster vaccine caused itchiness and bruising) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) solution for injection for Plaque psoriasis.    No Medical History information was reported.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) dosage was changed to at an unspecified dose. In December 2021, the patient experienced VACCINATION SITE BRUISING (COVID booster vaccine caused itchiness and bruising) and VACCINATION SITE PRURITUS (COVID booster vaccine caused itchiness and bruising). On an unknown date, the patient experienced INCREASED TENDENCY TO BRUISE (bruises easily). At the time of the report, INCREASED TENDENCY TO BRUISE (bruises easily), VACCINATION SITE BRUISING (COVID booster vaccine caused itchiness and bruising) and VACCINATION SITE PRURITUS (COVID booster vaccine caused itchiness and bruising) outcome was unknown.            No Concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Information has been received from a published literature article, referring to a 2 year old male patient. On an unknown date the patient was vaccinated with Rotavirus vaccine, live oral, pentavalent (manufacturer unknown) (strength, dose and lot # not reported), orally. The patient had been fully immunized. On an unknown date in 2013, during the patient's February 2013 school break, on the road of family vacation to a beach, the patient's old sister who had previously complained that she did not feel well, proceeded to vomit. The patient's old sister did not receive rotavirus vaccine. Over the next several days, the patient's old sister was mildly ill with abdominal pain, occasional vomiting, and diarrhea. Although she showed glimmers of improvement, 3 days later she awoke with bilous vomiting and periumbilical abdominal pain. On arrival at the closest pediatric hospital, the physician noted significant dehydration, administered ondansetron, attempted oral hydration, and thought that intravenous rehydration and basic laboratory tests were needed. The physician stated that she probably had gastroenteritis. The patient's old sister's laboratory results were notable for bicarbonate level of 10 mmol/L and an anion gap of 33. On hospital admission, bacterial stool culture and rotavirus antigen tests were ordered. After receiving hydration overnight, the patient's old sister recovered, and they left the hospital to resume their family vacation. On an unknown date in 2013, the patient experienced gastroenteritis rotavirus despite vaccination. Within 5 minutes of returning from the hospital, the patient's 5 year old brother vomited while attempting to reach the bath room. That night, the patient had vomiting and diarrhea, and misses the toilet. 6 of 6 family members of the patient had been ill within 2 weeks. Stool specimens of the patient included rotavirus of genotype G12P (vaccination failure). On an unknown date, the patient recovered from gastroenteritis rotavirus with no lasting effects. The outcome of vaccination failure was unknown. The reporter considered vaccination failure and gastroenteritis rotavirus to be related to Rotavirus Vaccine, Live, Oral, Pentavalent (manufacturer unknown). This is one of the three reports regarding the same article. The patient's sibling's adverse events were captured in 1506USA002868 and 1506USA003701. A copy of the published article is attached as further documentation of the patient's experience. Additional information has been requested.
Red raised firm area at left upper arm 7.5 cm x 11.5 cm  warm and tender to touch. Benadryl 25 mg 1 dose Zyrtec 10 mg daily x 5 days Famotidine 20 mg daily x 5 days Seen by nurse practitioner on 11/18/21 Physician to re-assess left upper arm on 11/20/21
After the shots, experienced the shingles/Suspected vaccination failure; shingles; itching; This 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pruritus. On an unknown date, the outcome of the vaccination failure, shingles and pruritus were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pruritus to be related to Shingles vaccine.     Additional Information: GSK receipt date: 5-June-2022 Reporter's comment: This case was reported by a patient via interactive digital media. After having the shots 4 years ago, the patient experienced the shingles, no pain, But the itching had just about drove him/her crazy. The patient advised to get vaccinated. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles was not provided.
Severe shaking for several hours-started 11pm on 3/28/22. Chills. Fever 101.1. Diarrhea. Headache. Brain fog. Tired.
Headache; Chills; Fever; Red rash; Burning rash; itchy rash at the injection site; Tender at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red rash), RASH (Burning rash), INJECTION SITE PRURITUS (itchy rash at the injection site), INJECTION SITE PAIN (Tender at the injection site) and HEADACHE (Headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced RASH ERYTHEMATOUS (Red rash), RASH (Burning rash), INJECTION SITE PRURITUS (itchy rash at the injection site) and INJECTION SITE PAIN (Tender at the injection site). On 19-Feb-2021, the patient experienced HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, RASH ERYTHEMATOUS (Red rash), RASH (Burning rash), INJECTION SITE PRURITUS (itchy rash at the injection site), INJECTION SITE PAIN (Tender at the injection site), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. Treatment included Tylenol
pt recv vax 6JAN99 & mom noticed edema 7JAN99;child c/o arm hurting;saw MD this AM & instructed to use warm compresses, edema @ site & warm to touch;
Vasovagal syncope episode immediately after vaccinination, with unconciousness lasting for approximately 1 minute.
Ipol administered after the excursion with no reported adverse event; The condition was 1.6C for approximately 35 hours due to a refrigerator malfunction with no reported adverse event; Initial information received on 05-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 5 years old female patient to whom Ipol administered after the excursion with no reported adverse event and the condition was 1.6 Celsius (C)  for approximately 35 hours due to a refrigerator malfunction with no reported adverse event , and it involved punctured  vaccine IPV (VERO) [IPOL].   The patient's past medical history, medical treatment(s),  and family history were not provided. The patient was not given any other vaccine    The caller sated that on an unknown date, the condition was 1.6 C for approximately 35 hours due to a refrigerator malfunction with no reported adverse event (product storage error) (latency : unknown)  On 14-Jun-2022, the patient received 0.5 ml   dose of suspect IPV (VERO) once,  (lot : T1E871M ; expiry date: 10-Oct-2022) via intramuscular route in the left deltoid for immunization. It was reported that Ipol administered after the excursion with no reported adverse event (poor quality product administered) (latency: same day)   Action taken : not applicable for both the events.  Outcome: unknown for both the events    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Per father, child seen at medical facility on 9-9-14 with Dx of erythema multiforme. Father also reported GI upset with vomiting and that child had been treated by mother with prednisone and hydrocortisone cream.
For 6 days, I was extremely fatigued.....had diarrhea on two of those days.....chills, achy, no appetite and lost 5 pounds.
Sudden injection site redness and warmth that started today.   Also complains of site tenderness that was initially sore, was improving, then on  04/20/2021 the tenderness worsened to the point it was the same as the day after injection.  She took Tylenol and/or Ibuprofen with improvement in pain.
WITHIN MINUTES AFTER GIVEN THE MODERNA VACCINE, SHE FELT HER BODY WAS ON FIRE. SHE STOOD UP AND THEN FELL TO THE FLOOR. SHE STARED AND MADE NO ATTEMPT TO TALK, "APPEARED TO PASS OUT" PARAMEDICS WERE CALLED AND WERE UNABLE TO GET THE PATIENT TO COMMUNICATE OR REACT TO ANY OF THEIR COMMANDS. HE HAD DIFFICULTY LIFTING HER LEGS AND JUST FLAPPED HER ARMS INSTEAD OF PLACING THEM WHERE THE PARAMEDICS WERE ASKING HER TO. SHE WAS TAKEN TO MEDICAL CENTER . PATIENT HAD EKG, CXR, LABS ALL NEGATIVE AND DISCHARGED AFTER A COUPLE OF HOURS.
I noticed that my existing tinnitus became much louder two days after the second dose. Since then the tinnitus has stayed loud and has not come down in volume to this day.
My arm from 7pm-7am exp pain, tingling and purple in color. On 12/21 went to employee health nurse told to take Ibuprofen went home. As of today still purple and yellow in 3 to 4 inches in bruise. I dint miss any days of work.
This spontaneous report as received from a nurse refers to a female patient of unknown age. Patient's pertinent medical history and drug reactions or allergies were not provided. On an unspecified date, the patient was vaccinated with the first dose of GARDASIL (route, dose, frequency, lot # and exp. date were not given). No other co-suspects were reported. No concomitant medications were reported. On an unspecified date, the patient was vaccinated with the second dose of GARDASIL (route, dose, frequency, lot # and exp. date were not given). On 31-AUG-2012, the patient was in the office for the third dose of GARDASIL that was late. The nurse mentioned that the third dose was due in March 2012. The patient was not experiencing any known symptoms. No treatment information was reported. Additional information is not expected.
Patient tested positive for COVID-19 by PCR on 3/24/21.  Received 2nd dose of Pfizer vaccine on 1/20/21.  Unknown if exposure to COVID positive person(s) or if patient had symptoms when tested.
Severe flu like symptoms. Body pain including headache, back, joints, etc.. 101 + degree fever. Dry heave vomit, sick to stomach. Diarrhea. Mental confusion and anxiety.
Dizziness, approximately 28 hours after dose Injection site pain, 4-5 hours after dose and continuing to time of this report Injection site swelling  Acetaminophen taken for pain
Child was inadvertently given a Hepatitis A vaccine in lieu of the Hepatitis B vaccine. No complications were reported at this time.
Patient experienced diffuse muscle weakness in all 4 extremities, beginning 2 days after the 2nd dose of the Pfizer COVID-19 Vaccine. It progressed equally in upper and lower extremities. 4 days after vaccination, he was unable to walk and couldn't stand from a seated position. Presented to the ER and had a 5 day hospital stay. His upper extremities graded 4/5 strength, his lower extremities graded 3/5. Initially throught to be Guillan-Barre Syndrome, he received 5 doses of IV IG over 3 days. Reflexes preserved throughout his stay. He was treated by physical therapy and occupational therapy throughout his hopsital stay. He improved dramatically over the last two days of his stay and was discharged home with home PT.
Information has been received from a physician via field representative, referring to a female patient of unknown age. Information about medical history, concurrent condition and concomitant therapy was unknown. On unknown dates, the patient was vaccinated with all three doses of GARDASIL or GARDASIL 9 (dose, strength, route, frequency, lot# and expiration date were unknown) for prophylaxis(product name confusion). On an unknown date, the patient was diagnosed with papilloma viral (HPV) type 16. The outcome of the event was unknown. The causality assessment was not provided by the reporter.
felt her heart was beating a little faster for a while; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 50 year-old female patient received bnt162b2 (COMIRNATY), administration date 23Aug2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEART RATE INCREASED (non-serious), outcome "unknown", described as "felt her heart was beating a little faster for a while". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Date Received: 07Oct2021; 17:18:06 UTC. Question: Call was warm transferred, NTID #, Reportum # . Per, call was transferred to her by USMI agent with INT-#. Documenting possible duplicate AE, e-transmitting report for review (50 years old, Female - age was obtained from original INT-#, was not able to capture it during my call). New AE information obtained from the caller. Caller did not provide any other personal information. Caller wanted more information on how the Pfizer-BioNtech Vaccine works. Caller wants to know what does the previous MI means when she said "primes" the immune system. She also wants to know how long the antibodies stay and how long we can produce antibodies. Question: Call was warm transferred, NTID #, Reportum # . Call was transferred to her by agent with INT-#. Documenting possible duplicate AE, e-transmitting report for review (50 years old, Female - age was obtained from original INT-#, was not able to capture it during my call). New AE information obtained from the caller. During the call, she mentioned that after getting the 1st dose, after a day or two she felt her heart was beating a little faster for a while, that's why she decided not to get the vaccine. She's not sure if that's the vaccines effect or maybe she's nervous or something, she's not really sure.  No follow-up attempts are possible. No further information is expected.
I can't tell you if 100 or 50 mcg is administered; Received third dose being not eligible; This spontaneous case was reported by a physician and describes the occurrence of INCORRECT DOSE ADMINISTERED (I can't tell you if 100 or 50 mcg is administered) and OFF LABEL USE (Received third dose being not eligible) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A, 012M20A and 021B21A) for COVID-19 vaccination.     Concomitant products included LOSARTAN for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Sep-2021, the patient experienced INCORRECT DOSE ADMINISTERED (I can't tell you if 100 or 50 mcg is administered) and OFF LABEL USE (Received third dose being not eligible). On 22-Sep-2021, INCORRECT DOSE ADMINISTERED (I can't tell you if 100 or 50 mcg is administered) and OFF LABEL USE (Received third dose being not eligible) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient take low dose steroids.  Patient did antibody test PCR test and it showed antibody did not register very high. Agent upon asking clarifying question about immunocompromised status , patient  stated that he is not.   This case was linked to MOD-2021-329820 (Patient Link).
MISSED TO TAKE THIRD DOSE; This spontaneous case (PVX2019-1179) was received from a pharmacist on 13-May-2019. It describes a female consumer who "missed to take third dose", while being on oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer took the first dose and the second dose of Vivotif on 07-May-2019 and 09-May-2019, respectively. Then, she missed to take the third dose on the scheduled time.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "missed to take third dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed to take third dose" was considered as not applicable.
Normal saline used to dilute the vaccine, incorrect diluent used. Vaccine administered. No adverse symptoms. Sterile water with no preservatives was the proper diluent.
First does had soreness of area of injection overnight., no other adverse reaction. Second does had the same soreness of area of injection overnight, in addition to bodyacnes and soreness, for about a day and a half.  After that I continues to experience fatigue, I go to sleep at night and have difficulty getting up in the morning due to feeling very fatigued.  It takes about an hour before I can feel like completing my day.  During the day I feel like I need a nap.  Before the shot I was able to complete my day as normal.