chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Anemia; He has been complaining about nausea; Fatigue; Abdominal pain started after the 2nd dose and he did not have it after the first; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 13 year-old male patient received bnt162b2 (BNT162B2), administration date 23Feb2022 (Lot number: fm0698) at the age of 13 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: IBUPROFEN. Vaccination history included: Bnt162b2 (Dose Number: 1, Dose brand: Pfizer, Batch/Lot No: 33036bd), administration date: 02Feb2022, when the patient was 13 years old, for COVID-19 Immunization, reaction(s): "Nausea", "Fatigue". The following information was reported: NAUSEA (non-serious) with onset 23Feb2022, outcome "not recovered", described as "He has been complaining about nausea"; FATIGUE (non-serious) with onset 23Feb2022, outcome "not recovered", described as "Fatigue"; ABDOMINAL PAIN (non-serious) with onset 23Feb2022, outcome "not recovered", described as "Abdominal pain started after the 2nd dose and he did not have it after the first"; ANAEMIA (non-serious) with onset 03Mar2022, outcome "not recovered", described as "Anemia". The events "he has been complaining about nausea", "fatigue", "abdominal pain started after the 2nd dose and he did not have it after the first" and "anemia" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of nausea, fatigue, abdominal pain, anaemia.  Additional Information: The patient had no known allergies. Prior vaccination within 4 weeks was reported as none. Treatment received for adverse event was reported as antacid. Prior to vaccination, patient was not diagnosed with COVID-19 and since the vaccination, patient was not tested for COVID-19. The reporter stated that after each dose the patient had expected immune response. The patient has been complaining about nausea, abdominal pain and fatigue that still persists. That abdominal pain seemed to be getting better but we took him to see his Doctor on 03Mar that is when he stated that the abdominal pain started after the 2nd dose and he did not have it after the first. The doctor had to press on his abdomen that day for him to notice the pain. That was the case for the next several days with him stating it was getting better. On 10Mar when he got home from school he said he had a sharp pain in his abdomen during one of his classes and the pain remained after that. The doctor suggested taking a blood sample and it came back with indications of anemia. Also took a specimen to check for blood in feces to check for an ulcer. That came back negative, but she wants one more before ruling a ulcer out. The patient has been referred to a GI specialist.  No follow-up attempts are possible. No further information is expected
Patient experience pain and numbing  and tingling from the injection site in right arm up through the neck and into the face. Numbness did not affect breathing but did last 12-18 hrs and stayed strictly on the right side of the body (arm, neck, face). There has also been severe joint pain throughout the body that started approx 24 hrs after injection and still lingering 10 days later.
First dose 1/15/21 - headache, fever, nausea, fatigue for 3-4 days after first dose.  Second does 2/25/21 - headache, fever, nausea, fatigue for 1-2 days after second does.  Mild but longer symptoms after first dose - stronger symptoms but shorter in duration after second dose.  My lung strength has continued to worsen. Working with Pulmonologist.
No known drug reaction at time of administration. Administered in am 3/28/2014. Onset of inconsolable crying that night 3/28/2014. Seen in clinic 3/29/2014, normal exam negative fluorescein exam. Crying did not resolve until 3/29 PM.
This spontaneous report as received from a physician refers to a patient of unspecified age and gender. Concurrent conditions and medical history were unspecified. On an unspecified date in May 2016 (reported as last week), the patient was inadvertently vaccinated with a dose of PEDVAXHIB (strength, dose, dose# and route unspecified) instead of the intended dose of MENACTRA. No adverse effects were reported. No product quality complaint (PQC)was involved. No further information was provided. Additional information is not expected as the reporter did not provide consent to follow-up.
pt recv 12AUG97 & pt devel a xanthogranuloma juvenile at or close to the inj site;
Pt was given the age +12 year COVID Pfizer vaccine instead of the age appropriate. Pt had no side effects, no complication.
Arm itching.  swelling from shoulder to elbow on outside of arm.  including injection site.
Left deltoid.   Pharmacist administered booster to a 17 year  10 month old person.  Pharmacist missed the year.  No adverse reactions.  This was sent in before  just resending in case the first did not get received.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 21-MAR-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion two times. The total cumulative excursion time of the first time was 136 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 40 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
first dose of SHINGRIX in February of 2020; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix in February 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 18-APR-2022 Reporter's comment: Reporter was the pharmacist. The pharmacist reported that he has a patient that had her first dose of Shingrix and was inquiring about further dosing. AE (Adverse event) filed. Warm transferred to Medical Information. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
19JUN95 lt arm @ inj site became red/swollen & itched; rt ankle became red/swollen; 20JUN05 pt could not bear wt on rt ankle very painful; second red/raised area on lt arm;saw PMD @ ER who prescribed ATB & anti-inflammatory;dx cellulitis
Information has been received from a physician concerning a 67 year old female who on 19-NOV-2009 was vaccinated with a dose of PNEUMOVAX 23 (LOT# 664864/1365Y). On 20-NOV-2009 the patient experienced some injection site reaction like arm enlarged, hot to touch, swollen down to the elbow and redness. No further information is available at this time of the report. This is one of the two reports from the same source. Follow up information was received from a health professional concerning the patient with allergy to CATAPRESS patch who on 19-NOV-2009 was vaccinated with a first IM dose of PNEUMOVAX 23 (Lot No. 664864/1365Y) into her right deltoid at approximately 10:00 am. There was no illness at the time of vaccination. Concomitant vaccination included COREG, potassium chloride, NORVASC, therapy illegible, ALDACTONE, NIFEREX, EFFEXOR XR, aspirin, CALTRATE, ezetimibe (+) simvastatin (MSD), DIOVAN HCT, VICODIN, alendronate sodium (MSD) and cholecalciferol. In October 2009, the patient was vaccinated with a dose of influenza virus split virion 3v vaccine inactivated (manufacturer unspecified). On 20-NOV-2009 the patient experienced redness and swelling at the vaccination site. The patient also experienced itching. The patient's arm was swollen to the elbow joint. There was no fever. At the time of the report, the patient recovered on an unknown date. No further information is available.
A non-serious spontaneous report of inadvertent administration of expired H1N1 was received from a registered nurse/health professional concerning a nine-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The original expiration date was 08-Apr-2010, which was reassigned to 29-Mar-2010. On 31-Mar-2010, the patient received the second dose of expired H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable and the event was considered to be resolved.
Pt said he was almost paralyzed on his right side when he woke up Saturday morning after his vaccination early Friday.  He fell that morning and then later in the weekend fell at a restaurant.  He says that his whole right side still does not feel good.  It feels heavy and numb.
Information has been received from a physician concerning a female who on 11/30/1998 was vaccianted once with 0.5 ml subcutaneous dose of varicella virus vaccine live. In June 2005, the patient experienced breakthrough chickenpox. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
p/ pt recv vax pt exp chickenpox w/approx 35 macules, papules & vesicles over entire body.on 7/6/98 seen by MD who noticed 30-40 lesions
Fever; This is a spontaneous report received from a Pfizer-sponsored program and a contactable other HCP. A patient of unspecified age and gender received first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as Dose 1, Single for Covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, the patient experienced fever. The outcome of the event was unknown.  No follow-up attempts were possible; information about lot/batch could not be obtained.
pain from the fillings; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A female patient received bnt162b2 (BNT162B2), administration date 11Apr2021 (Batch/Lot number: unknown) as dose 1,single for covid-19 immunisation. Relevant medical history included: "tooth cavities" (unspecified if ongoing), notes: She has since gone to the dentist to have cavities filled and has been experiencing pain from the fillings. Concomitant medication(s) included: TYLENOL; IBUPROFEN. The following information was reported: TOOTHACHE (non-serious), outcome "unknown", described as "pain from the fillings".  Additional information:Caller states her daughter received the first Pfizer Covid vaccine on 11Apr2021. She has since gone to the dentist to have cavities filled and has been experiencing pain from the fillings. She wants to know how long does she need to wait before she takes Ibuprofen to treat the dental pain. Tylenol has not been working for her. Will e-transmit as potential AE. Response: Referred caller to HCP and spoke from attached document - use of fever reducing drugs and pain relievers (v2.0).She has since gone to the dentist to have cavities filled and has been experiencing pain from the fillings.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Started feeling terrible in late August 2021.  My legs turned red and I had gone to the ER.  The doctor thought it was cellulitis and prescribed antibiotics.  The problem didn't go away and it was spreading.  I went back to the ER a week or so later and the doctor thought I was having an adverse reaction to an antibiotic.  On October 29, I started vomiting blood.  I required surgery and nearly died.  I lost 7 units of blood.  I was on life support for a couple days during that time.  This was a Medical Center.  They said it was from prior drinking, but my liver is fine outside of mile fatty liver disease.
2 weeks after injection noticed a large oval shaped rash on left arm at and below injection site,. approximately 3 inches long by 2 inches wide.   The area is  slightly sensitive and painful with a burning feeling.  The area is not itchy at this time.  I believe this is what experts are calling COVID Arm attributed to the Moderna Vaccine.
Up all night; Sweating; body Aches; Coughing; Fever; Chills; Joint pain; Headache; Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing), HYPERHIDROSIS (Sweating), PAIN (body Aches), POOR QUALITY SLEEP (Up all night) and PYREXIA (Fever) in a male patient of 45-year-old who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included LISDEXAMFETAMINE MESILATE for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness). On 26-Mar-2021, the patient experienced COUGH (Coughing), PAIN (body Aches), PYREXIA (Fever), CHILLS (Chills), ARTHRALGIA (Joint pain) and HEADACHE (Headache). On 28-Mar-2021, the patient experienced HYPERHIDROSIS (Sweating). On an unknown date, the patient experienced POOR QUALITY SLEEP (Up all night). At the time of the report, COUGH (Coughing), PAIN (body Aches), PYREXIA (Fever), CHILLS (Chills), ARTHRALGIA (Joint pain) and HEADACHE (Headache) had not resolved and HYPERHIDROSIS (Sweating), POOR QUALITY SLEEP (Up all night) and PAIN IN EXTREMITY (Arm soreness) 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.   Treatment medication included acetaminophen
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose 03/02/2021, pfizer,Lot# EN6205 2nd dose: Pfizer 03/23/2021, Pfizer lot#  EN6208 Diagnosed covid positive:06/26/21 Exposure:Home Symptoms:Headache, cough,nasal congestion, rhinorrhea,  diarrhea.
Migraines (3 days), fever (1 night), night sweats (3 nights), body aches (1 day), arm pain (3 days)
Client received Td injection right deltoid. Reports redness, itching, warm to touch at site for 2-3 days. Reports she followed up with PMD 10/23/03. Sole complaint at time of report is (pain comes and goes) at injection site. Plans to follow up with PMD if pain contines.
When arose 8/31/02 felt bad with chills, achy, nausea, headache took Tylenol and returned to bed sx cont. until 4pm 9/1/02, getting better. Tylenol for fever, aching.
Pfizer 12y &up vaccine use for COVID-19 under Emergency Use Authorization (EUA): Pt is in for nurse only visit for 2nd Pfizer COVID vaccine. 1st vaccine administered on 4/11/22. LPN staff nurse administered 2nd dose and this was 4 days too early.
Pt complaint of headache  and chills,  V/S checked ,ice pack applied, Pt.took own meds I tab Excedrin. 1205- pt stated feeling a lot better. 1215- went home with no further worsening of symptoms.
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   The nurse reported that, on 04-AUG-2016, the patient received an improperly stored VARIVAX (Lot #: L042265; Expiration date: 26-OCT-2017) for prophylaxis (Dose, route and anatomical location were not reported). No adverse effects reported. Temperature/Time frame: >-15°C but <-10°C (>5°F but < 14°F) excursion reported for 46 hours 10 minutes (worst case) Previous temperature excursion:   >-15°C but <-10°C (>5°F but < 14°F) excursion reported for 133 hours and 30 minutes (worst case) The call was not because of a "data logger". There was no Product Quality Complaint (PQC) involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1701USA005376:
Severe injection site pain starting 3 hours post injection, culminating in severe pain 14 hours post injection, continuing into 2nd day.
Admitted 03/23/12, inconsolable crying and bloody stools x 3 days. GI consult.
more asthma than before; body ache; Symptoms of COVID-19; cough; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Symptoms of COVID-19), COUGH (cough), ASTHMA (more asthma than before) and MYALGIA (body ache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Gastritis and Drug allergy (Patient is allergic to Aspirin). Concomitant products included PROBIOTICS NOS for Gastritis, VITAMINS NOS for an unknown indication.    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced COVID-19 (Symptoms of COVID-19) and COUGH (cough). On an unknown date, the patient experienced ASTHMA (more asthma than before) and MYALGIA (body ache). At the time of the report, COVID-19 (Symptoms of COVID-19), COUGH (cough), ASTHMA (more asthma than before) and MYALGIA (body ache) outcome was unknown. Not Provided      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.   This case was linked to MOD-2021-092618 (Patient Link).
Abdominal cramp, crying, massive diarrhea.  Gave as much fluids as possible and kept changing diaper.
No additional AE reported; Patient was inadvertently administered PNEUMOVAX 23 via PNEUMOVAX 23 Prefilled Syringe on 10/10/2022. Expired on 07/01/2022; This spontaneous report was received from pharmacist and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 10-OCT-2022, the patient was vaccinated with a dose of expired pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, lot #T036820, expiration date: 01-JUL-2022, administered for prophylaxis (dose, strength, and route of administration were not provided) (expired product administered).  There was no adverse event reported.
site pain and swelling x days 1-5; fatigue, chills fever x day 2-3; herpetic whitlow x weeks 2-3 after dose. Narrative:
Mother stated that MD stated that pt had the "worst case of vaccine-induced chicken pox he had ever seen." Pt treated with Pedialyte, Aveeno bath and Tylenol. MD told reporter that he didn't think VAE report was necessary. Pt had 7 new pox the day of report.
Area 6 x 5 red, hot rash. Fever patient had MD visit on Monday for other reason. MD looked at it and said shot caused cellulitis. MD has patient on KEFLEX for this.
Starting day 2 of receiving 2nd dose severe nausea, stomach pain, overall weakness, fatigue, shortness of breath,  which carried on for months.  PCP gave her ondansetron for nausea, then took her off ondansetron and replaced with famitodine.  Nothing truly was helping things just continued.   I, finally emailed her pcp  and requested a referral for a Gastroenterologist due to all that's been going on and the weight loss.  We finally had an appt. on April 4, 2022,  He wanted to do a endoscopy.  That afternoon after arriving home from the Dr. She was on the toilet and had a synchopy episode and was slumped over on the toilet, but was able to ring her medic alarm to alert me.  We got her back to bed, blood pressure was low, she was alert and just kept saying I don't feel well, got her electrolite water and stayed by her side till her blood pressure raised to a normal level.  Approx. a half hour later, her medic alert went off again, slumped on the toilet again but unconscious I checked her pulse and heartbeat, she was breathing, then she shook a moment with eyes wide open and could not hear me I had to yell, she came around when my son was on the phone with 911, they came and took her to the hospital
pt recv vax 31OCT96;w/in 10min pt devel red warm area below site of inj followed by overall itching w/o rash;c/o aching in lt arm shoulder & neck;numbness in lt hand;given DPH;
aproximately 5 min after receiving the vaccine, client started c/o light headeness,dizziness, hot flashes,and a numb lip, cold and shivering. they started o2 at 4liters via nasal canula and gave her 2 Benadryl 25mg oral tabs. At 10:40 she said she felt better, not dizzy, lip not numb, and wasn't feeling cold. She said she would contact her pcp and let him know. She felt good enough to drive off.
Onset of redness only 1hr after shot - Overnight arm began to swell & is warm to touch - MD cannot rule out cellulitis based on exam.
1. Swollen lymph nodes--axillary, left upper chest, arm.  Also left side of face--cheek, jaw,  throat (tonsil).  This began within half and hour of vaccination and lasted about 3-4 days.  Also happened similarly on second dose (4-16-21, same location).  2. Left upper arm pain.  Still ongoing at this time (June 6, 21).  Mild to moderate. Occasionally up into neck to behind ear.  Difficult to lift left arm from straight out (away from body) further up.  Was not affected by second dose.