chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received a first dose of Moderna vaccine and she is eleven years old.  Patient parents registered patient through the vaccine portal with an incorrect DOB and subsequently registered in the database with same incorrect DOB as a 20 yo when in fact the patients true DOB is different.  When patient arrived for the second Moderna vaccine, the vaccinator questioned the patients parents and determined that the patient was not 20 yo and did not administer second dose.  No adverse events reported from vaccine.
Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. Since 01-OCT-2015 these patients were inadvertently vaccinated with improperly stored VARIVAX (Merck) (lot # L001335, expiration date 13-JAN-2017; dose, frequency and route not reported). No adverse experiences had been reported. This is one of two reports received from the same reporter. Additional information has been requested.
41 yo male patient with history of renal transplant on immunosuppressive therapy, diabetes, CAD, CHF, HTN, HLD, OSA presents with a 9 day history of fatigue, congestion and a 2 day history of nausea/vomiting and intermittent fevers, but no respiratory symptoms. Pt received Pfizer COVID-19 vaccination: first dose 3/18 and second dose 4/8. Pt tests positive for COVID on 4/24; CXR on 4/30 showed no acute findings. Admitted for additional hyponatremia, AKI, and hyperkalemia. Pt remained on room air. Received 2 doses of remdesivir while inpatient and felt significantly improved afterwards. He was set up for outpatient COVID follow ups via telehealth and given a COVID home monitoring kit.
Erythema, edema to deltoid, I saw this patient in ER and an unable to answer many questions such as 13,21.  This is a healthy 4.5 year old little girl.  She had her routine immunizations yesterday at the Clinic included polio, tetanus, and MMR.  Tetanus and MMR were given in the left deltoid and she has developed some pain and swelling to that area.  She has not had a fever.  No vomiting, no diarrhea, no shortness of breath, no cough, and no other symptoms.
This spontaneous report was received from a pharmacist concerning a 60 years old female patient with allergy to sulfa. On 20-JAN-2013, the patient was vaccinated subcutaneously with a 0.65 ml dose live ZOSTAVAX lot # (H019035), Exp date: 17-JAN-2014 for shingles. No other co-suspects were reported. The patient had no relevant concomitant medications. The patient's relevant past drug history was unknown. The patient stated that on 21-JAN-2013, the patient noted a local reaction at and around the injection site on the left arm. This reaction included swelling, redness and warmth. The area was further described as a dark red spot about the size of a quarter. There was hardness at the injection site. The area of swelling, redness and warmth extends out from this dark red spot about 5 inches. Relevant lab was unknown. As of 23-JAN-2013, the patient no longer took the live ZOSTAVAX. As of 23-JAN-2013, the patient continued to experience the swelling, redness and warmth at and around the injection site. No treatment information was reported. The relatedness for the event was unknown for live ZOSTAVAX. Additional information has been requested.
Patient presented to the ED and was subsequently hospitalized for chest pain,  Unstable angina due to arteriosclerosis of autologous artery coronary artery bypass graft , positive fecal occult blood test within 6 weeks of receiving covid booster vaccination.
Pt called hospital to say she went to doctors due to heat and swelling in a 3 inch radius of left arm.  Doctor thought MRSA cultured site and gave pt antibiotics.
Patient with light headed feeling, heart palpitations, Feels dazed and syncopal.  Stated visual defect present.  VS stable.  EMS called for consultation.  Evaluated.  Orange juice given and pretzels.  Released to family after refusing transport to local healthcare facility. Patient will eat before dose 2 in 21 days.
Fever102.2. Nausea,diarrhea, severe lower back pain.  All lasting approx. 14 hours.  Left arm cellulitis from injection site to elbow, on going.
This spontaneous report as received from a nurse refers to a 19 month old patient of unknown gender. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On 25-MAY-2017, the patient was vaccinated with improperly stored dose of VAQTA (lot # M039202, expiry date 11-MAR-2018, dose and route of administration were not provided). The vaccine was stored between 0 and 1 Celsius degree for 60minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. No product quality complain was involved. This is one of two cases received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1705USA014610:
pt recvd vax approx 20-30 yrs of age & was vaxed w/2 dose of MMR & lab eval revealed neg titers; pt revaxed & then tested pos to rubella;
Dizziness, Headache, Arthralgia, FATIGUE, CHILLS, PAIN/SWELLING INJ SITE, Narrative:  Other Relevant History:
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 20-Feb-2021, PAIN IN EXTREMITY (Sore arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.  Treatment information was not reported.
This literature marketed report was received from the authors of a published literature article, concerning 2476 adult patients (aged 40 +/- 16 years) of unknown gender. No information regarding the patients' medical history or concurrent conditions was provided. The objective of the study was to further elucidate the relationship between Hepatitis B virus (HBV) and diabetes. The authors examined the data derived from the Survey from years 2005-2010. Survey was a program of studies designed to assess the health and nutritional status of adults and children. The authors excluded 13902 subjects who were younger than 20 years of age at the time of screening interview and 851 subjects without body mass index (BMI) information. Then, they excluded 933 patient whom hepatitis B serology was not available and 32 subjects, whose diabetes status could not be determined. From 15316 patients included in the analysis, 4063 patients were vaccinated with doses of hepatitis B vaccine (recombinant) (manufacturer unknown) injection (dose and route of administration were not reported) on unspecified dates. The vaccination was assessed by self-report. There were no concomitant therapies reported. 91.07% of the vaccinated patients received all 3 doses of hepatitis B vaccine (recombinant) (manufacturer unknown) and the remaining patients received less than 3 doses. As the analysis was mainly based on the serological results, the authors did not separate the subjects who received all 3 doses or less than 3 doses. It was reported that the immunization status of the patients was assessed by hepatitis B surface antibody (HBsAb), hepatitis B core antibody (HBcAb) and hepatitis B surface antigen (HBsAg) testing. Positive hepatitis B immunization status was based on positive result of HBsAb test and negative results of both HBcAb and HBsAg tests. Any other combination of results was considered as negative hepatitis B immunization status. Out of 4063 patients vaccinated with hepatitis B vaccine (recombinant) (manufacturer unknown), there was no serological evidence of immunization for hepatitis B in 2476 cases. Therefore, HBV vaccination was deemed to be unsuccessful in those 2476 patients, who were reported to be vaccinated. The outcome of the events was not reported. The reporters considered the event to be related to the therapy with hepatitis B vaccine (recombinant) (manufacturer unknown). They stated that as the titer of HBV declines with time, the high vaccination failure rate in this sample set could be a time-related issue, however they could not exclude other causes from the limited information available. Additional information has been requested.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On unknown dates, the patients were vaccinated with VARIVAX for prophylaxis. Concomitant therapies included sterile diluent. On unknown dates, the patients experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event was unknown. The reporter considered incorrect product storage and no adverse event to be not related to VARIVAX. Sender's Comments: US-009507513-1708USA012769.
Patient returned to pharmacy that she had received the vaccine from presenting with swelling, pain and warm to the touch, in the same arm the vaccine was given. It occurred 2 days after receiving vaccine. It was located further down the arm than where the vaccine was given. I advised her to take benadryl and monitor the swelling/pain. If it continues to worsen, go to ER.  She should advise her MD of reaction and weigh risk vs benefit of receiving 2nd dose. Advised her not to get 2nd dose.
Severe lower back pain Severe  thigh muscle pain both legs Strong neck pain Nausea for two days Dizziness when standing or walking Upper arm pain, both arms
Fever/chills, muscle aches, headache, itching, cough, difficulty breathing, fast heart beat.
pt recvd vax; seen in urgent care 4 days p/ DTP shot given in rt deltoid; pos cellulitis per MD;
This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. On 15-NOV-2104 the patient was vaccinated with the first dose and on 17-APR-2015 with the second dose of VAQTA (strength: 25/0.5 (units not provided), 0.5 ml, intramuscular). No adverse effects were reported. Additional information is not expected as there was no consent to follow up contact.
Case number PHEH2013US016744 is an initial spontaneous report received from a nurse on 06 Aug 2013. This is also a quality complaint report (reference number: 245488). This report refers to a 23-year-old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with RABAVERT (batch number: 473011C) at a dose of one ml, intramuscularly, with first dose on 07 Sep 2011 (day 0) in right deltoid, second dose on 14 Sep 2011 (day 7) in left deltoid and third dose on 05 Oct 2011 (day 28) in right deltoid. On 15 May 2013, she had equivocal rabies titer (insufficient result). She required a booster dose of rabies. Reporter assessed the case as serious (medically significant). Outcome of the event was not reported. No other information was provided.
Since flu mist given - upper airway congestion, cough- non production intermittent cough. Worsening.
Wrong sibling sat in the chair; thus, the other sibling vaccines was administered. MCV4 was administered and not recommended for a 9 year old. Informed parents regarding the wrong administration of MCV4 and the possible side effects.
Period arrived on time but cramps more painful than usual. 8/10. Tylenol isn't working.
Following 2nd dose of Shingrix, pt has been experiencing shooting pain where he previously had shingles rash. He has had shingles twice before. I advised him to use topical numbing agent to treat pain.
Patient came into store 12/19 complaining of arm pain/redness. She states swelling has gone down since the first night but very red still.
Pt reported to me on 6/13/21 that she has had a sore arm at the site of injection from 2nd dose of the Moderna vaccine for almost 3 months. She received her dose on 3/25/21 & has had a sore arm ever since. I told her she could try ibuprofen or Tylenol and that she should reach out to her MD about this.
Rash on trunk of body; Rash on trunk of body that was tingly; Rash on trunk of body that was painful; Nose bleed; swollen gums; This is a spontaneous report from a non-contactable pharmacist. A 35-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via intramuscular route of administration on 08Apr2021(at the age of 35-year-old) as a single dose for COVID-19 immunisation. Medical history included depression. The patient previously received Vistaril and experienced drug allergy. Concomitant medications included trazodone (MANUFACTURER UNKNOWN), bupropion hydrochloride (WELLBUTRIN) and iron (MANUFACTURER UNKNOWN) all for unknown indications from an unknown date and unknown if ongoing and sertraline hydrochloride (ZOLOFT) for unknown indication from an unknown date and was ongoing. It was unknown whether the patient had received any other vaccines within four weeks prior to the vaccination. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. On 21May2021 the patient experienced rash on trunk of body that was tingly and painful and on an unknown date in May2021 patient experienced nose bleeds and swollen gums. The patient had been out of  Zoloft five day prior to events. Patient was recommended follow up with PCP (primary care physician) and he went to urgent care where was given amoxicillin and a topical ointment for the irritation and also refilled Zoloft prescription after initial presentation. On 24May2021 phone follow up with the patient revealed pain was gone and rash had subsided. The event rash on trunk of body that was tingly and painful resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of rash on trunk of body that was tingly and painful and included treatment with amoxicillin (MANUFACTURER UNKNOWN) and topical cream (MANUFACTURER UNKNOWN). Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the events rash on trunk of body that was tingly and painful was recovered on an unknown date in May2021; while that of nose bleeds and swollen gums was unknown.  No follow-up attempts are possible. No further information is expected.
Pt vaccinated with Influenza wife stated that her husband is allergic to antihistamines. He took the RU-Tuss from about 9NOV90 t6rough 13NOV90 symptoms were; SOB, swelling around the eyes, blurred vision & difficulty urinating.
Approximately 3 hours after receiving H1N1 vaccination noticed throat and back itchiness - noted hives on neck and back. Took an antihistamine and hives cleared in a few hours. Occ. itchiness remain but very mild- no further hives. No further antihistamine doses taken.
Allergic reaction; threw up in the first 5 minute; he was not feeling well; This is a spontaneous report from a contactable consumer (patient's mother). A male patient (reporter's son) of an unspecified age (13 unspecified units) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0186), via an unspecified route of administration on an unspecified date in 2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Reporter stated, so patient got his first vaccination here in (withheld) and he threw up within the first 5 minute on an unspecified date in 2021 and the doctor that administered it said he had an allergic reaction on an unspecified date in 2021 so reporter just she was concerned and want to know what to watch for or if anything like this happened to another young child you know between 12 and she guess 15. Just you know see what if there was any concern here that's a normal thing or you know. The patient was not feeling well on an unspecified date in 2021. When confirmed the vaccine as Pfizer COVID 19 Vaccine, reporter stated, yes, it was, and he was 13. The outcome of the events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Injection site developed induration measuring 8x3 cm, after 20 minutes area decreased in size.
Admission Date: 6/1/2022 Discharge Date:  6/3/2022  PRESENTING PROBLEM: Acute pancreatitis without infection or necrosis [K85.90] Vomiting, intractability of vomiting not specified, presence of nausea not specified, unspecified vomiting type [R11.10] Acute pancreatitis, unspecified complication status, unspecified pancreatitis type [K85.90] COVID-19 virus infection [U07.1]   HOSPITAL COURSE: Patient is a 69y/o female with a history of ampullary adenocarcinoma status post Whipple procedure in 2018, hypothyroidism, obesity, depression and who had recently tested positive for COVID and who presented with abdominal pain along with nausea and vomiting. She was recently placed on eyedrops and prednisone for itchy red eyes and has been following with Ophthalmology as an outpatient.   In the emergency department she was found to be afebrile with a lipase of  262. She was not hypoxic. CT A/P was done and showed acute interstitial pancreatitis, status post Whipple procedure without findings of local recurrence and stable suspected benign lesions within the spleen. She was placed on IVF,anti-emetics and analgesics. She was placed on remdesivir for her COVID infection but was not hypoxic nor febrile. Pancreatitis etiology was unclear.  Gastroenterology was consulted and they thought that her pancreatitis could be related to COVID versus Whipple anatomy.  They recommended that patient be started on a diet and advanced as tolerated.  Patient had no further nausea or vomiting and her abdominal pain did improve.  She was placed on a diet which she tolerated without any nausea or vomiting. GI did order workup for pancreatitis. Lipid panel did not reveal any hypertriglyceridimia.   GI stated that if patient was tolerating her diet, she could be discharged home and follow up with them as an outpatient in 4-6 weeks time.   As she had improvement of her abdominal pain without any vomiting and was tolerating her diet-she was discharged home in stable condition 6/3/2022.
This child was given DTaP in the left deltoid on 08/17/01, pain, swelling, redness and warmth, hard 08/20/2001. Treatment : supportive care.
Received flu vaccine on 10/1/13 in LFA. Pain at site later in the day going up left side of neck and around the back of neck. Pain not improved and by 10/4/13 had pain in neck and shoulder with tingling in left fingers.
Red knot that is now the size of a fifty cent piece, warm to the touch, itching, muscle soreness all around the injection site and lump.
Vomiting; Low grade fever; Arm extremely sore; Achy all over; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 12 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunization. The following information was reported: VOMITING (non-serious), outcome "unknown", described as "Vomiting"; PYREXIA (non-serious), outcome "unknown", described as "Low grade fever"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm extremely sore"; PAIN (non-serious), outcome "unknown", described as "Achy all over". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Event took place after use of product.  Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
10min p/vax pt devel throat tightness then blotchy red rash on cheeks;transient dizziness;throat tightness lasted 10";DPH needed;
Pt reports showering Tuesday night and when she came out of the shower she noticed hives on her face. She then stated she wasn't sure if it was hives, but she had red bumps that formed all over her face. She didn't take anything to treat it, it went away on its own the same day. Patient was counseled to keep an eye on it and to report if any other symptoms occur.
Patient developed persistent fevers and weakness and loss of appetite that continued for about 3 weeks after getting the vaccine.  There was a delay of about a day from getting the vaccine that he developed symptoms. He came to the hospital at today, 2/23/2021 because of the persistence of his symptoms. Vitals were stable and within normal range, but he had elevated creatinine to 1.66, unknown baseline. Troponin was also elevated to 0.08 without symptoms of ischemic heart disease. EKG was normal.
Four hours after the two vaccinations I began to feel my throat closing up inside - no swelling outside - and then developed 102F fever and felt very chilled. Fever did drop late the next day. Felt weak.
Severe tingling and shooting pain when the injection was given.  Continued shoulder pain increasing in severity over the next few days. On 11/11/2013 went to my personal physician.  Shoulder was x-rayed.  It was determined that the shot was given high and into the shoulder joint. Am now on a course of steroids to attempt to relieve the inflammation.
This is a spontaneous report from a contactable physician.  A 30-years-old male patient received bnt162b2 (Formulation: Solution for injection Lot Number: EL3247), dose 1 via intramuscular, administered in Arm Left on 04Mar2021 as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications.  The patient experienced right foot pain on 04 Mar 2021. Patient developed right foot pain 4 hours after vaccination and lasting 18 hours. Resolved spontaneously without treatment. The action taken in response to the event for bnt162b2 was not applicable. The outcome of the event was recovered.
Pain at injection site, (right arm) ever since date of immunization. Employee states he was seen by his primary care doctor on 1/8/16 and has been treating the arm pain with cold compress and ibuprofen as advised by his primary care physician.
Client complained of tingling/numb feeling in left arm from elbow to fingers 5 minutes after receiving COVID vaccine.  Hands and fingers warm to the touch, injection site clear.  Observed and vital signs stable.  Numbness and tingling resolved 45 min after start.  Client home with instructions to follow up with primary care.
6x7cm area of "splotchy" redness and mild warmth. No tenderness.
Several hours post vax pts thigh became very swollen down to and including the knee. Pt was treated with ibuprofen.
No additional AE reported; A vaccine coordinator reported VARIVAX was administered after a temperature excursion.; This spontaneous report was received from a vaccine coordinator referring to a patient of unknown age and gender. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 07-APR-2022, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dose and route were not reported; lot # u025791 was evaluated and changed to the valid lot # U025791, expiration date: 19-AUG-2023) for prophylaxis (product storage error).         It was reported that the suspect vaccine was exposed to a temperature of minus 11.83 degree Celsius for a time frame of 15 minutes; Previous temperature excursion included 9.37 degree Celsius for a time frame of 2 hours and 30 min.    No additional adverse event (AE) information was provided (no adverse event).  This is one of the multiple cases reported by the same reporter.; Sender's Comments:  US-009507513-2204USA002815:
Patient got her pfizer vaccine  and developed redness and itching on her chest 15 minutes after. She said her face felt slightly itchy as well. She was given 2 tablets of diphendydramine 25 mg. Her symptoms did not progress. She was monitored for a  half hour then returned home. No addition medical intervention was given.