chrisvoncsefalvay/vaers-outcomes huggingface dataset:
15 minutes after temp excursion started 2 doses were given to twin boys from opened vial of IPOL/ No reported side effects; Initial information received on 10-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA103572 same reporter.  This case involves a four years old male patient who received vaccine IPV (VERO) [IPOL] lot PIA461M, expiry date: 03-May-2020 via unknown route in the right deltoid On 09-Apr-2019.  It was reported that, excursion for 60 minutes with max temperature 9.11 Celsius. Products: ActHIB, Daptacel, IPV (excursions-open - 2 unopened), Pentacel, Tubersol, Adacel, Menactra.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL) for Immunisation; MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation.  It was a case of actual medication error due to Incorrect product storage.  It was reported that, excursion yesterday afternoon around at 14:15 for 60 minutes with max temperature 9.11 Celsius. Products: ActHIB, Daptacel, IPV (excursions-open - 2 unopened), Pentacel, Tubersol, Adacel, Menactra. Caller reports that 2 patient got IPOL vaccination form open IPOL at 14:30  No reported side effects.   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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.  Documents held by sender: none.
1st shot 11 months ago; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose, 11 months ago of reporting date).   On an unknown date, the patient received 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 details were provided as follows: The patient self-reported this case. The age at vaccination was not applicable for this report. The patient missed second shingrix shot, which led to incomplete course of vaccination. The patient waned to know what was the plan, if he/she needed to start over or he/she should get the second shot would that be ok. The follow-up would not possible as no contact details were available.
pt recv vax 27AUG97 & 21NOV97 pt devel chickenpox ( 5 lesions);
LARGE WELT, 2X4" AROUND INJECTION SITE. ITCHES, WARM TO THE TOUCH.
Breakthrough case admission after 3 vaccines Moderna 2/11/21 Lot# 015M20A;  Moderna 3/11/21 Lot# 044A21A;  Moderna 10/23/21 Lot# 012F21A;
Pt recvd 3 doses of Hep B vax & 12FEB92 titers results were neg; pt had not responded to Recombivax; 21FEB92 recvd booster dose of Engerix-B;
Information has been received from a health professional refers to an unspecified patient. No concurrent or historical conditions were reported. On 19-JAN-2015 the patient was vaccinated with a dose of expired M-M-R II (lot # J000201, expiration date 09-JAN-2015), subcutaneous which was potency supported. No adverse effects reported. The patient had not sought medical attention. Additional information has been requested.
RED FACE AND CHEEKS; FACE HOT TO TOUCH; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204B21A, and expiry: 11-DEC-2021) dose was not reported, administered on 27-NOV-2021 for prophylactic vaccination (Dose number in series 1). No concomitant medications were reported. On 01-DEC-2021, the patient experienced red face and cheeks. On 01-DEC-2021, the patient experienced face hot to touch. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from face hot to touch on 02-DEC-2021, and was recovering from red face and cheeks. This report was non-serious.
I had cold type symtoms with a stufy head, nose, sore throat and extreme fatigue as well.
Mother called stating her son had shots in Center on Wednesday and now the area where he received one of his injections is red, slightly swollen, and itchy. Nurse asked what arm it is. Mother stated it is the left arm. Nurse informed mother that client received a Hep A and Varicella injection in that arm. Mother denied any pain, fever, or any other symptoms.
Left upper arm red, swollen, hardened area, warm to touch.  3 in wide x 2 in long.  Diagnosis: cellulitis per doctor.  Prescribed Levoquin 50mg.  Treatment: meds and warm compresses x 14 days.  Update on 06/23/2003.
pt seen on 10/2/19 with right sided neck pain headache fatigue weakness dizziness
Left upper arm - red, warm, tender, swollen - noted 24 hour after vaccines given. Left arm 26 1/2 cm, Right arm 22 1/2 am in ? past secondary to per mother.
Anxiety  185 heart rate  Affected mood and emotions   Migraines Neck  Back  Shoulders  Spine  Extreme pain  Fatigue Stiffness  Weak
covid vaccine breakthrough case  All Moderna  dose 1 1/3/21  011L20A dose 2  1/31/21  011L20A dose 3  10/28/21  088D21A dose 4  4/21/22  002M21A
This non-serious spontaneous case, initially received from other health professional on 19-Oct-2018 concerns a 26-year-old, adult, female patient. The patient did not have any medical history and did not take any concomitant medications at the time of vaccination. On 09-Oct-2018, the patient was administered FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: left deltoid, dose: 1.5 ml, batch number: 252235 and expiry date: 30-Jun-2019]. At the time of this report, no adverse reaction was reported. This case: 201804663 was cross-linked to the original case: 201804657 reported by the same reporter.
Moderna vaccine was administered outside of clinic - reported by patient ? NO LOT NUMBER WERE SUPPLIED  J96.00 ACUTE RESPIRATORY FAILURE 2/14/2022 ATRIAL FIBRILLATION W RAPID VENTRICULAR RESPONSE ESRD (END STAGE RENAL DISEASE)
This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient administered with 0.25 instead of 0.5ml for 2nd booster from vial with blue cap) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR4504B) for COVID-19 vaccination.     It was unknown if the patient had any allergies to medications, food, and other products. It was unknown if the patient ever had COVID positive test or diagnosis. It was unknown if any other vaccines were given to the patient within 1 month prior to Moderna COVID-19 vaccine. Concurrent medical conditions included Diabetes (Unknown if any recent change in status such as improvement or worsening). On 27-Jul-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Jul-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient administered with 0.25 instead of 0.5ml for 2nd booster from vial with blue cap). At the time of the report, ACCIDENTAL UNDERDOSE (Patient administered with 0.25 instead of 0.5ml for 2nd booster from vial with blue cap) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. The reporter stated that the patient was administered with a volume of 0.25 ml of Moderna COVID-19 Vaccine booster dose only presentation (vial with blue cap) for a 2nd booster dose. The reporter was not aware of any Adverse events after the vaccine was administered for the patient and did not know if any treatment was given, or if the patient was under any concomitant or regular medication. The vaccination date for the first dose, second dose and first booster dose were unknown. The height of the patient was unknown. No treatment information was provided by the reporter. This case was linked to MODERNATX, INC.-MOD-2022-615296 (E2B Linked Report). Sender's Comments:  MODERNATX, INC.-MOD-2022-615296:Other patient (Same Reporter).
Minor pain, redness, and excessive swelling at vaccination site; Minor pain, redness, and excessive swelling at vaccination site; Minor pain, redness, and excessive swelling at vaccination site; This case was retrieved from a download on 01JUN2023.  A 39-year-old male patient developed "minor pain, redness, and excessive swelling at vaccination site" (PT: Vaccination site erythema, PT: Vaccination site pain and PT: Vaccination site swelling) following the administration of BioThrax (anthrax vaccine adsorbed) for immunisation.  On 11MAY2023, the patient received BioThrax (dose: 7plus and lot number: 300209) via intramuscular route in the left arm.  On 12MAY2023, the patient had minor pain, redness, and excessive swelling at the vaccination site.  The outcome of the reported events was unknown at the time of this report.  The action taken with BioThrax with respect to the reported events was not applicable.  The patient's medical history/allergies, current illness, and medications at the time of vaccination were reported as not applicable.  Company comment: A consumer received BioThrax via intramuscular route in the left arm and developed minor pain, redness, and excessive swelling at vaccination site (vaccination site erythema, vaccination site pain and vaccination site swelling). Considering the case information, the causality of vaccination site erythema, vaccination site pain and vaccination site swelling is assessed as possible with BioThrax. The case is considered non serious as per medical assessment.; Sender's Comments: A consumer received BioThrax via intramuscular route in the left arm and developed minor pain, redness, and excessive swelling at vaccination site (vaccination site erythema, vaccination site pain and vaccination site swelling). Considering the case information, the causality of vaccination site erythema, vaccination site pain and vaccination site swelling is assessed as possible with BioThrax. The case is considered non serious as per medical assessment.
Today when secretary called mother to remind her of child's appt 8-4-08 for GARDASIL #3. Mother told secretary that child had left arm pain after vaccine on same day and "tingling of fingers" on left hand. That night child had fever. The next day child had a very bad headache and "muscle twitches" in back. Patient refused next GARDASIL vaccine.
Pt recvd 1st dose of Hep B vax on 4FEB92 & devel h/a, swelling of throat, unable to breathe, hoarse; Pt seen in ER tx DPH & Adrenalin; next day pt to ER w/recurrent swelling of vocal cords w/hoarseness; edema of vocal cords;
woke up on April 11th with itchy scalp. woke up on April 12th with hives on my face, and swollen eye lid. went to doc, told me to take Claritin. hives progressed over next few days to full body, EXTREMELY itchy, dinner plate sized welts. took oatmeal baths everymorning and slathered myself in cortisone cream. it was awful. went to primary care doc in Hospital on April 13th. was prescribed oral steroids. doc thought is was a bad allergic reaction to tree pollen, which was bad at the time, and affects me every year. was still in excruciating state of itchiness that Friday the 15th. doc prescribed Pepcid. along with Allegra. both helped a lot. finally saw an allergist on May 17th. was told it was a heighten immune response to the modern booster. doc- said he had seen 20 patients this spring with same symptoms within 2 weeks of getting the moderna booster. said he also talked with other allergists around the country who were seeing same thing. told me to take 2 Allegra a day and that it would take a few months for it to calm down. I still have hives but they are controlled by the h1 and h2 blockers.
Information has been received from a physician concerning a 62 year old female who on 21-MAr-2008 was vaccinated with a dose of ZOSTAVAX vaccine (Oka/Merck). On 30-MAR-2008 the patient was seen in emergency clinic for painful rash on left neck area. The patient was told that she had shingles and was treated with VALTREX. Subsequently, the patient recovered from shingles. This is one of several reports received from the same source. Additional information has been requested.
Initial information received on 31-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to 2018SA212665, 2018SA212615, 2018SA212648 and 2018SA212627 (Same reporter). This case involves a two months old male patient who was vaccinated with first dose of PENTACEL (Batch number: C5529AA, expiration date: 04-Oct-2019 via unknown route in unknown administration site on 23-Jul-2018, concomitant medication PREVNAR 13 and Rotovirus. It was an actual medication error due to inappropriate reconstitution technique. It was reported that a lyophilized powder portion of ACT-HIB that was not given from a box of 5 single doses of PENTACEL and the reporter was unsure which one of the 5 patients who received doses from this lot didn't get the ACTHIB portion. It was reported that the patient had no reaction. 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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. List of documents held by sender: none.
On November 2 I was diagnosed with Prostatitis and taking SMZ/TMP for 14 days, 2 pills each day. Also got COVID booster on that day. I am having bouts of vertigo and increasing dizziness starting around November 6. The prostatitis symptoms have gone away. Fever gone and no more pain when urinating.
A serious spontaneous report of hyperbilirubinemia has been received from a registered nurse/health professional concerning a female infant, subsequent to her mother receiving H1N1, intranasal. This case is linked to MEDI-001038. The patient's past medical history and concomitant medications were not reported. The patient did not receive H1N1, intranasal. On 20-Jan-2010, the patient's mother received H1N1, intranasal for an unknown indication. The infant was delivered vaginally on 16-Jun-2010 at 39 weeks gestation. The infant was a female who weighed seven pounds and four ounces; apgar at one minute was eight and at five minutes was nine. There were no complications at delivery for mother or the infant. While hospitalized after birth, the infant experienced hyperbilirubinemia and received photo therapy. She was discharged with her mother on 20-Jun-2010. The outcome  of hyperbilirubinemia was unknown.
This case is linked to case number 2013SA097404, 2013SA116606 and 2013SA116605 (same reporter). Initial report received from healthcare professional on 18 September 2013. The three patient, whose gender, date of birth, age at the time of event and concomitant medications were not reported, had received intradermal dose of FLUZONE INTRADERMAL vaccine, batch number: UT4725AA (dose number and anatomical site of administration were not reported) on 09 September 2013. The patient's medical history and illness at the time of vaccination were reported was not applicable. It was reported that on 09 September 2013, after receiving FLUZONE ID vaccine, the patients experienced mild local reactions with no associated or radiating pain and only a small amount of redness or swelling. The corrective treatments and laboratory investigations were not reported. The event local reactions were resolved quickly over a day or two. (Recovery date was not reported). Documents held by sender: none.
Covid Arm_  Red swollen and itchy  Went away about 4 days after shot then came back
noticed some spotting issues with her period, it comes on and off for about "15-20 and some days"; noticed some spotting issues with her period, it comes on and off for about "15-20 and some days"; This is a spontaneous report from a contactable consumer. This consumer reported similar event for her Daughter and Daughter particular classmate. This is daughter report.  This consumer (parent) reported that a 16-year-old female patient (daughter) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on Jul2021 at single dose for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Jun2021 for COVID-19 immunization. Reporter wanted to know if we have additional information on menstrual irregularities as a reported adverse event after getting the Pfizer BioNTech Covid-19 Vaccine. Reporter also requesting for medical advice. Reporter stated that her daughter received the first dose of the Pfizer BioNTech Covid-19 Vaccine on 28Jun2021 and her second dose on Jul2021. Reporter's daughter noticed some spotting issues with her period, it comes on and off for about 15-20 and some days. The outcome of events was unknown.  The lot number for [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101170062 same drug and AE, different patient
This spontaneous report was received from a medical assistant referring to a 20 year old male patient. The patient's medical history, drug reactions/allergies and concomitant medications were not provided. On 13-NOV-2017, the patient was vaccinated with the first dose of VARIVAX subcutaneously, in the right deltoid, for prophylaxis (lot# L049532, expiration date: 08-DEC-2017) in the physician's office. On 16-NOV-2017, the patient went back to the office for a laboratory appointment, the staff read wrong the provider note, and he received a second dose of VARIVAX subcutaneously, in the left deltoid, for prophylaxis (lot# L049532, expiration date: 08-DEC-2017). Both doses were reconstituted with sterile diluent (manufacturer unknown). The patient was vaccinated at a Private doctor's office with private founds. The reporter described that the event was related to human error and was not a result of product confusion. The patient did not complain for any side effects, no adverse effects were reported and no product quality complaint was involved. No prescription drug treatment for the experience was required. The vaccines did not undergo temperature excursion.
Two weeks post vaccination, red vasicular at injectionsite along with a few vasicular areas on trunk.
When she received the shot she had pain in the injection site; Tired some days; This morning she had a lot of stomach pain; Very watery diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 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 (First dose), for Covid-19 Immunisation. The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset 09Mar2021, outcome "unknown", described as "This morning she had a lot of stomach pain"; DIARRHOEA (non-serious) with onset 09Mar2021, outcome "unknown", described as "Very watery diarrhea"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "When she received the shot she had pain in the injection site"; FATIGUE (non-serious), outcome "unknown", described as "Tired some days".  Additional information: Patient received the second dose of the vaccine on Saturday, this morning she had a lot of stomach pain and very "watery" diarrhea, when she received the shot she had pain in the injection site and she felt tired some days, she did not have chills or fever.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Developed hives to his feet and chest. We observed him, family deferred antihistamines or other interventions at this time.
This spontaneous report was received from a Pharmacist concerning a patient of unknown age and gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On 06-AUG-2018, the patient was vaccinated with an improperly stored dose of (Wistar RA 27-3) M-M-R II lot # N027781; expiration date: 08-AUG-2019 (dose and route of administration were not reported) for prophylaxis, which had a temperature excursion of 47°F to 77°F (56F) for 15 days on unspecified dates. There were no previous temperature excursions and no digital data logger involved in recording the temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Sender's Comments: US-009507513-1808USA012996: US-009507513-1809USA006251: US-009507513-1809USA006252: US-009507513-1809USA006253: US-009507513-1809USA006254: US-009507513-1809USA006255: US-009507513-1809USA006256: US-009507513-1809USA006257: US-009507513-1809USA006259: US-009507513-1809USA006260: US-009507513-1809USA006261: US-009507513-1809USA006262: US-009507513-1809USA006263.
Day 2 - fever and muscle aches Day 3 - chest tightness and discomfort; tingling and numbness in both arms and hands
Headache which had started a few hours after shot became pounding headache overnight. Soreness in arm about 3 inches in diameter around injection site. These were same symptoms as in first shot. Second shot side effects were only soreness in arm. Difference is chills this third shot, in middle of night, around 1:00 AM ET. Could not stop shaking for about 5 minutes and body locked in fetal position. Spent all of the day in bed until headache cleared around 4:45 PM ET on 12/25. Drank about 30 oz water within 15 minutes of getting shot; kept drinking water and earl grey caffeinated tea during 12/24 and got up sporadically to drink water when not dizzy with headache. Ate one small banana morning of 12/25 and took reported vitamins.
Patient's mother states child started having mild fever on the night of 04/26/2019. Child woke up on 04/27/209 with uncontrollable vomiting, high fever, diarrhea, and was lethargic. Child also had a rash on right arm that was 3 inches long and 1 inch wide. Child had mild fever on 04/28/2018. Child was seen by pediatrician. As of 05/01/2019 the symptoms have resolved.
Information has been received from a physician concerning an unspecified patient of unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medication were not reported. On an unknown date, the patient was vaccinated with a dose of PROQUAD (dose number, dose, anatomical location, route of administration, lot number and expiration date were not provided) for prophylaxis, reconstituted with 0.4 % saline solution (manufacturer unknown), instead of the sterile diluent (MRK). No adverse effects reported. Additional information has been requested.