chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant, referring to a 24 year old female patient. The patient did not have any medical history, drugs allergies, or concurrent conditions; and was not taking any concomitant medications. On 15-DEC-2017, an unspecified patient was vaccinated with her first dose of GARDASIL 9 intramuscularly, lot # N018273, expiration date 17-JUN-2019, for human papillomavirus (HPV) vaccination (strength, dose and frequency were not reported). On 02-JAN-2018, the patient was called for an unspecified reason and the patient explained that on an unspecified date, after receiving GARDASIL 9, an itchy rash on face developed. The medical assistant reported that the patient was informed to call back if hives developed or rash worsened. The patient sought medical attention and she did not receive any treatment for the adverse events. Diagnostic laboratories were not performed. At the time of reporting, the outcome of itchy rash on face and hives was unknown. Additionally, the causality assessment between itchy rash on face and hives with GARDASIL 9 was not provided.
lightheadedness; Vaccine-Related Anxiety (include misc mental health); Pt encouraged to monitor bp at home and follow up with pcp if noted to be 140/90 consistently.; This is a spontaneous report from a non-contactable other hcp reported that. A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot Number: EN6205), dose 1 via an unspecified route of administration on an unspecified date as 1st DOSE, SINGLE DOSE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced lightheadedness, vaccine-related anxiety, patient encouraged to monitor bp at home and follow up with pcp if noted to be 140/90 consistently. The patient underwent lab tests and procedures which included blood pressure measurement: 140/90. Therapeutic measures were taken as a result of lightheadedness. Outcome of the event lightheadedness is recovering, anxiety is unknown, and pt encouraged to monitor bp at home and follow up with pcp if noted to be 140/90 consistently is reported as unknown (at this point of time).  No follow-up attempts are possible. No further information is expected.
been sick for 3 days; throwing up part of it.; This spontaneous case was reported by an other health care professional and describes the occurrence of ILLNESS (been sick for 3 days) and VOMITING (throwing up part of it.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (been sick for 3 days) and VOMITING (throwing up part of it.). At the time of the report, ILLNESS (been sick for 3 days) and VOMITING (throwing up part of it.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment were reported.
Mild erythema no swelling at both arm at site of injection, no systemic symptoms. Supportive care, cold compress.
Event occurred after 2nd vaccine. Patient was diagnosed of Covid Ascorbic acid, Tylenol Discharged Home
received his first Fluzone Quadrivalent vaccine 0.5mL on 21Oct2019 and then received his second Fluzone Quadrivalent vaccine 0.25mL vaccine on 18Nov2019 with no AE; Initial information received on 27-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an 8 years old male patient who received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] and reported that patient received his first Fluzone Quadrivalent vaccine 0.5ml on 21oct2019 and then received his second Fluzone Quadrivalent vaccine 0.25ml vaccine on 18nov2019 with no AE (underdose).   The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 21-Oct-2019 he also received 1st dose of the same vaccine lot UT6709MA via intramuscular route in the right deltoid. On 18-Nov-2019, he also received 2nd dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT6709MA via intramuscular route in the right deltoid  It was a case of actual medication error due to vaccine underdose.  No adverse event was reported.  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.
pt recv vax 16SEP97 & had congestion on 17SEP97 was seen @ hosp & instructed to given saline nose drops;mom mixed 3 tbsp salt to 1 cup of h20 & used as nose gtt;pt immed stopped breathing & was taken to sheriffs office CPR performed to hosp. The autopsy report states laryngospasm.
Pt noted left arm swelling on 6/1/18 and was prescribed MEDROL Dose Pack by outside urgent care provider. Pt did not start steroid therapy but has now reported symptom improvement (by 6/5/18). Pt continues to have slight swelling and pruritis in left arm. Pt denies any shortness of breath or swelling in right arm.
Shingles with rash, raised welts, blisters, itching & nerve pain.  Presented to physician 7 days after onset of first symptoms.  Initially treated by patient with oral Allegra 24-hour OTC and externally applied hydrocortisone cream  After diagnosed by physician, treated with 7-day course of Valacyclovir 1g 3xd,  Also used externally applied Benedryl cream and Ben-Gay lidocaine cream as needed for itch & nerve pain.   Outcome as expected,
I have developed a small rash on my upper left thigh... about the size of a quarter.
arm swollen, achiness & redness around inj site, pain in legs & paresthesia in feet;sx confused by MD as GBS;seen by MD, neurologist & rheumatologist MD;
No additional AE; HCP called to report inadvertent administration of RECOMBIVAX HB to a patient on 08/30/2023 after experiencing a temperature excursion. Additional vaccines during the temperature excursion were administered to multiple patients (See AE case #02467645; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 30-AUG-2023, the patient was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, 0.5 milliliter, lot #X006977, expiration date: 01-OCT-2025, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion foe 6 hours 5 minutes in -0.4 degree Celsius (Product storage error). Previous exursions occured on unknown dae for 32 minutes in 0.5 degree Celsius and 2 hours 1 minute in 1 degree Celsius. No additional adverse event was reported.
Swelling, erythema of extremity at the location where the injection occurred within 48hrs.  Pt also has systemic symptoms-fatigue, nausea.  Treated with Motrin and Benadryl.
A very mild fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (A very mild fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (A very mild fever). At the time of the report, PYREXIA (A very mild fever) outcome was unknown. Not Provided    Action taken with mRNA-1273 in response to the events was not applicable   No concomitant product use was provided by the reporter. No treatment medication was provided.
Redness and rash appeared on my forehead above the right temple 3 days after the (05/05/2016) shingles immunization; each day the rash developed slowly in size, slight bubbling, and very slight swelling; after 9 days, my right eye became very red, bloodshot, and a small bubble appeared on each of my eyelids; no itching was associated with the rash; on day 9, I also began infrequently to experience sharp pains shooting down the rash and into my eyelids; I treated the rash with bag balm for four days, but switched to Calamine lotion on day 10. It had a very effective drying impact on the skin and stopped the little weeping I was getting from slight pocks in my skin. Today I saw a physician and ophthalmologist who prescribed Prednisolone drops 2x/day for my right eye and Acyclovir 800 mg tablets 5x/day for shingles.
Initial report received on 11/2/2005 from a health care professional. A 20 year old pregnant female with no significant medical history received an intramuscular injection of Menactra, lot number U1784AA on 11/1/2005. On 11/2/2005 she took a pregnancy test and it was positive. Her last menstrual period was on 9/23/2005. The patients past obstetrical history is negative for any previous pregnancies. Seriousness criteria other medically significant (OMIC). Follow up information received on 2/13/2006 from a health care professional Per the reporter, the patient had a miscarriage the week of 11/17/2005. No other information was provided. The case was upgraded to seriousness bases on this new information.
Tic appearing behavior-suspected to be seizure activity r/t immune response to DTaP vaccine. Had similar response for brief period of time after 15 month vaccines including DTaP. Activity was transient. Eye rolling.
This spontaneous report as received from an officer manager referring to a currently 1 year old male patient. No information was provided regarding the patient's medical history and concurrent conditions. The patient's concomitant medications included sterile diluent (MERCK STERILE DILUENT).  On 30-MAR-2018, the patient was vaccinated with an improperly stored dose of VARIVAX (dose and anatomical location and route of administration were not reported)  lot # M046004, expiration date: 18-NOV-2018 indicated for prophylaxis. The vaccine had not had any previous temperature excursions as recorded by a data logger. On an unknown date, VARIVAX had temperature excursions of   -14C to -10C  for a time frame of 7 minutes which was called by a data logger. There were no adverse effects reported. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1805USA000841: US-009507513-1805USA000922: US-009507513-1805USA000923: US-009507513-1805USA000928: US-009507513-1805USA000926: US-009507513-1805USA000927: US-009507513-1805USA000921: US-009507513-1805USA000924:
This initial spontaneous report was received from a healthcare worker referring to multiple unspecified patients of unknown ages and genders. There was no pertinent medical history or drug allergies/drug reactions reported. The reporter stated that on unspecified dates, the patients were vaccinated with unspecified number of doses of improperly stored (Oka/Merck) VARIVAX injection (lot # K008824, expiration date 19-JUN-2016, lot# L011083 expiration date 01-APR-2017 and lot# K002927 with expiration date 26-FEB-2016, strength, dose and route were not provided). There was no concomitant medication. No adverse experiences were reported. This is one of two reports received from the same source. Additional information has been requested.
Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium.
left arm is swollen; low grade fever of 101.2F; A spontaneous report was received from a consumer concerning a 71-years-old  female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events left arm is swollen, low grade fever of 101.2f.  The patient's medical history was not provided. Concomitant medications reported were high cholesterol meds, hypertension meds, sickle cell disease meds for drug use for unknown indication.  On 17 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 024M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 17 Feb 2021, the patient experienced the event(s) left arm is swollen, low grade fever of 101.2f. Safety to follow up given.  Treatment details included none.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, left arm is swollen, low grade fever of 101, 2f was unknown.
Culture pos pertussis on 28AUG93 p/exhibiting sx previously; not hospitalized;
Received immunizations early afternoon (12:50 appt.) parent called @ 4:23 pm. to report hives scattered over body (started 2 1/2 hrs after immunizations) seen 01-09-02-resolved. Unsure if secondary to vaccines or not.
Started crying @ 300pm-could not be consoled in anyway-cried for approx 3 hrs. APAP given-slept approx 15 min-woke up started crying again. DPH given @ 6:30 w/ no further crying-no T
This case was reported by a physician via sales rep and described the occurrence of injection site pain in a 18-year-old male patient who received BEXSERO. Previously administered products included BEXSERO with an associated reaction of adverse event (1st dose received on an unknown date and experienced injection site soreness, redness and warmth. See case US2016GSK156435). On an unknown date, the patient received the 2nd dose of BEXSERO .5 ml. On an unknown date, less than a year after receiving BEXSERO, the patient experienced injection site pain, injection site warmth, injection site redness and injected limb mobility decreased. On an unknown date, the outcome of the injection site pain, injection site warmth, injection site redness and injected limb mobility decreased were recovered/resolved. The reporter considered the injection site pain, injection site warmth, injection site redness and injected limb mobility decreased to be related to BEXSERO. Additional details were provided as follows: This case was previously reported to a doctor. The age at vaccination was not reported. The field representative reported that the doctor's patient experienced injection site arm extreme soreness with difficulty moving arm, redness and warmth at injection site lasting for 3 days after 2nd vaccination of BEXSERO. The vaccination date was reported as May 2016, but it was not clear if it belong to 1st or 2nd dose of vaccine.
Severe soreness at injection site, difficulty with overhead activities more than 1 week after injection.
kicked my ass; This case was reported by a consumer via interactive digital media and described the occurrence of feeling bad in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 11th November 2022, the patient received the 2nd dose of Shingles vaccine. In November 2022, less than a week after receiving Shingles vaccine, the patient experienced feeling bad. On an unknown date, the outcome of the feeling bad was recovered/resolved.   It was unknown if the reporter considered the feeling bad to be related to Shingles vaccine.     Additional Information: GSK receipt date: 12-Nov-2022 Reporters comment: This case was reported by a consumer via  interactive digital media. The patient received second dose of Shingles vaccine yesterday (day before reporting) and he/she stated that it kicked his/her butt for about 24 hrs. Additional Supportive information: The duration of the event was 24 hours. As per narrative it kicked my ass for this conservatively event coded as feeling bad.
Information has been received from a physician and nurse concerning an 18 month old male who was vaccinated PO with three doses of Rotateq (lot numbers not available). On 25-SEP-2007 the patient developed intussusception and was hospitalized for 2 days. An abdominal x-ray was performed in hospital and the results were suspicious for intussusception even though a diagnosis of intussusception was not made. Subsequently, the patient fully recovered and was discharged from the hospital on 26-SEP-2007. There was no product quality complaint. Additional information has been requested.  10/16/07 Received vax record from pcp.  VAERS database updated w/same.  Record faxed to CDC. 10/23/07 Reviewed hospital medical records which reveal patient experienced crying, colicky abdominal pain, malodorous stool & bright yellow vomiting x 1 day.  Exam revealed diffuse abdominal tenderness.  Peds surgery consult done.  Tx w/contrast enema & reduced IS.  Admitted 9/24-9/25/07 for observation s/p reduction.  Progressed well & d/c to home.  Returned to ER on 9/26 w/abdominal pain, bloody stool.  Recurrent IS reduced w/barium enema.  3rd abd US s/p reduction was WNL.  Admitted 9/26-9/27/07 for observation.  Progressed well & D/C to home. FINAL DX: Intussusception, recurrent, reduced x 2 by enema.  Records faxed to CDC.
swelling of the face and tongue.  lightheaded.  headache.  soreness and some disorientated, as well as severe dryness of the mouth.
This spontaneous report as received from a medical assistant refers to a female patient of unknown age. The patient was vaccinated subcutaneously with her first dose of GARDASIL (lot number not reported) in October 2011 and the second dose in September 2012. No other co-suspects were reported. No concomitant medications were reported. The patient had not yet received the third dose. No adverse effects reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
About 24 hours after injection had onset of ocular swelling, progress to tongue swelling (Obvious swelling), shortness of breath, diffuse flushing and hives  Went to ER, given Epinephrine
This spontaneous report was received from a registered nurse referring to a 4 month old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not provided. On unknown dates, the patient was vaccinated with improperly stored doses of ROTATEQ, orally, lot # N021308, expiration date 05-MAR-2019 (strength, dose, frequency and anatomical location were not reported) for prophylaxis. The vaccines were reconstituted with properly stored sterile diluent. There was no adverse effect reported. The administered doses of vaccines experienced the temperature excursion of 9 to 25 (8.6) degrees Celsius for 16 minutes. Data logger was involved. There were no previous excursions reported. This report was not associated with a product quality complaint.
Patient was asked to be observed for 30 minutes due to a previous serious reaction to IVP dye.  About 20 minutes after she received her vaccine, she felt chest pain and claustrophobia.   She refused an epi pen.  She took 50mg of diphenhydramine.  She quickly said that she felt better, but we monitored her blood pressure, pulse, and pulse ox.   We also called a paramedic, they arrived shortly and evaluated her.  She refused to get treatment.   Her vitals were all normal, she was drowsy from the diphenhydramine.  The chest pain and feeling of claustrophobia were gone.  She worked at a school and the school nurse checked on her throughout the rest of the day, and she was feeling fine.  She was very nervous about the vaccine, and her reaction could have been anxiety related (although she felt fine after her vaccine).
This case was reported by a other health professional and described the occurrence of underdose in a 21-year-old male patient who received HAVRIX pediatric (batch number N3431?, expiry date 19th February 2016). On an unknown date, the patient received HAVRIX pediatric .5 ml. On an unknown date, an unknown time after receiving HAVRIX pediatric, the patient experienced underdose. On an unknown date, the outcome of the underdose was unknown. It was unknown if the reporter considered the underdose to be related to HAVRIX pediatric. Additional information: This 21 years old was inadvertently given a pediatric dose of HAVRIX (720 EL.U).
arm weakness; discomfort; This case was reported by a other health professional via call center representative and described the occurrence of weakness of arms in a 61-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced weakness of arms and arm discomfort. On an unknown date, the outcome of the weakness of arms and arm discomfort were not recovered/not resolved.   The reporter considered the weakness of arms and arm discomfort to be related to Shingrix.  Additional details were reported as follows: About 8 weeks before the time of reporting, the patient received a dose of Shingrix. The patient experienced constant arm weakness and discomfort. Before the patient go back to receive 2nd dose in the next week, the patient just wanted to inform that, the 1st dose did leave the patient with some long-term arm weakness and discomfort but nothing else. The patient stated that having a physician assistant (PA) as a daughter helped the patient because she encouraged the patient to do less 12 ounce curls and pick up the dumbbells more. The patient took her advice and stated we should see the discomfort and weakness was real and unexpected.
Numbness Lt arm, weakness of left arm, decreased reflexes on L, decreased sensation arm L.
Death certificate received by state health dept on this child. Autopsy is pending. Cause of death unknown. Per F/U autopsy 4/15/02: No anatomic, metabolic or toxicologic cause of death found; thymic and pleural petechiae. The decedent was reportedly found unresponsive in her crib in a supine position with a comforter covering her head on 2/15/02.
General seizure 5/5/06 45 hrs after DTaP #4 Infanrix, Seizure 05/05/05 24 hours after DTaP #3 Pediarix.
This is a spontaneous report from a contactable consumer (patient herself). A 69-years-old female patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number- Unknown) via an unspecified route of administration, administered on unknown date as DOSE 2, SINGLE for covid-19 immunisation. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number- not reported) via an unspecified route of administration, administered on unknown date as Dose 1, single. Patient had has low immune system. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experiencing chills, headache and fever. The outcome of event was not unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Day 1: muscle soreness and headache that persisted for 3 days; Day 2: Rash on back; Day 3: Rash becomes itchy and spreading to chest and face.
pt recvd vax; mom called to state pt had cried since shot;cannot be consoled; has used coll cloths on inject site; inc fever; took to hosp er;