chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from an office manager concerning a 28 year old female with no medical history or allergies, who on 12-JUN-2007 was vaccinated intramuscular with a third 0.5mL dose of Gardasil (lot #657005/0314U). There was no concomitant medication. Subsequently several hours after being vaccinated the patient experienced nausea and vomiting. No laboratory diagnostic studies were performed. The symptoms improved within 24 hours. The patient sought unspecified medical attention. At the time of the report, the patient had recovered. No product quality complaint was involved. Additional information has been requested.
I began to vomit from 8 am to 6pm. Could not keep anything down, including water and medicine for my intense headache.
Mid-back - 4 mm scab with surrounding swelling & redness.  Total ~15-20 sores ranging from 1-2 mm pink papules to 1 mm raised papules with 7-8 mm red base.  1-2 with scabs-no big fluid-filled blisters.  Breakthrough varicella after vaccine.  Contagiousness discussed; BENADRYL or other antihistamine, calamine lotion.  Call if concerns.
Experienced right side aside pain 3 days after vaccination and broke out with shingles rash 6 days after vaccination
patient received 1 mL of FLUZONE QIV instead of 0.5 mL/No AE; Initial information was received on 23-Sep-2020 regarding an unsolicited valid non-serious case from a Nurse.  This case is linked to cases 2020SA263223, 2020SA263253 and 2020SA263260. (same reporter)  This case involves a 58-year-old female patient who received a 1 mL dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE QUAD T] instead of 0.5 ml (overdose).  Medical history, medical treatment, vaccination, and family history were not provided.  The patient did not receive any other vaccine concomitantly.  On 22-Sep-2020, the patient received 1 mL dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [lot UJ475AA, expiry date: 30-Jun-2021] instead of 0.5 mL via an intramuscular route at the right deltoid for prophylactic vaccination (overdose).  It was a case of overdose (actual medication error case, latency same day).  At the time of report, 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.
This case was reported by a nurse and described the occurrence of inappropriate age at vaccine administration in a 2-month-old male patient who received FLUARIX QUADRIVALENT (batch number 75XC, expiry date 30th June 2015). On an unknown date, the patient received FLUARIX QUADRIVALENT. On an unknown date, an unknown time after receiving FLUARIX QUADRIVALENT, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown. Additional information received: A 2 month old patient received FLUARIX QIV instead of PEDIARIX.
Minor pins and needles all over the body/Random pins and needles all over the body; Right arm pit got fat; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Minor pins and needles all over the body/Random pins and needles all over the body) and VACCINATION SITE SWELLING (Right arm pit got fat) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 06F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Sep-2021, the patient experienced VACCINATION SITE SWELLING (Right arm pit got fat). On 17-Sep-2021, the patient experienced PARAESTHESIA (Minor pins and needles all over the body/Random pins and needles all over the body). At the time of the report, PARAESTHESIA (Minor pins and needles all over the body/Random pins and needles all over the body) outcome was unknown and VACCINATION SITE SWELLING (Right arm pit got fat) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021 at 10:01 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Oct-2021 at 10:01 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The patient age was reported as 79.10 years.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  On 27-Oct-2021, At excursion time 09:00 AM, temperature was 29, at 10AM temperature was 32, total doses given for the day was 116, condition of vaccine prior to vaccination was not frozen, vaccines were moved to fridge on 29-Sep-2021 and 05-Oct-2021, vial was moved to clinic on 27-Oct-2021. 2 and 4 vials were moved to clinic 29-Sep-2021 and 05-Oct-2021 respectively. Vaccine BUD date was 29-Oct-2021 and 04-Nov-2021.  On 27-Oct-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 41, 9 AM: 29, 10 AM: 32, 11 AM: 43, 12 AM: 43, 1PM: 43, 2 PM: 46, 3 PM: 46, 4 PM: 46 and 5 PM: 45.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. The temperature recordings were taken by using a Fisher brand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.
Moderna was given for dose 1 and Pfizer was given for dose 2.  28 days apart.  Patient did not have any side effects as of today.
17 year old male received an adult 1.0 ml dose of Havrix; 17 year old male received an adult 1.0 ml dose of Havrix; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 17-year-old male patient who received HAV (Havrix adult) (batch number KM72C, expiry date 18th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th February 2022, the patient received the 1st dose of Havrix adult 1 ml and Havrix Pre-Filled Syringe Device. On 16th February 2022, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The case was reported by Clinical Supervisor. The patient received an adult dose of Havrix, which led to overdose and adult product administered to child. No symptoms were reported. The reporter consented to follow up.
About 5 min after immunizations were given the pt was standing and fainted. He fell and Mom and sister were the only ones in the room with him. We heard Mom yell for help and we ran in the room and had him lay on the floor. He sat in the office for 1 hr. After while he ate sugar and drank fluids and he was good after that.
acute chronic inflammatory demyelinating polyneuropathy (CIDP); This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer unknown), for COVID-19 immunization. The following information was reported: CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (medically significant), outcome "unknown", described as "acute chronic inflammatory demyelinating polyneuropathy (CIDP)". The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Chronic inflammatory demyelinating polyradiculoneuropathy with the suspect drug Comirnaty cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Patient is not 18 years old (COVID19 Moderna vaccine is recommended in the EUA for 18 years old and older). No adverse outcomes. Patient's mother accompanied her at the vaccination clinic and gave verbal consent.
Arm was broken out in welpy, red hives from above where vaccine was given to the elbow of left arm.  Swollen area that moved from injection site to inside of arm over a couple of days
Pt complaining of dizziness, headache, chills, tingling to forehead. Pt initially stated dizzy and headache were normal for her but symptoms continued and pt was assessed.  No other symptoms noted.  Pt was offered transport to hospital and signed AMA.
24 hours after receiving the vaccine, the patient noticed redness about 4 inches below the injection site. The red area was about 4" x 3". It was warm to the touch. Patient stated "it feels like a bee sting". He also complained of abdominal pain on his right side; like he had been punched. Patient went to the doctor and was prescribed Prednisone.
Patient did not return our multiple calls to inform them of the expire vaccine that they received.  The patient did not call back in any capacity to complain about any adverse events. The manufacture informed us via written statement that patients "maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration." Revaccination was not advised.
Syncope/vertigo; passed out and fell onto floor of bedroom upon awakening; admitted to OV Hospital from ER; CT Scan, MRI, numerous tests conducted; no formal conclusions reached.  Released to home bedrest. Continued symptoms include dizziness, nausea, insomnia
PT RECEIVED 3 VACCINES. AFTER RECEIVING LAST INJECTION WHICH WAS HPV IN L ARM, PATIENT BEGAN TO FEEL WEAK. PATIENT'S HEAD WENT TO THE LEFT SIDE. PATIENT BECAME UNRESPONSIVE TO NAME. SKIN PALE. PULSE PRESENT. BODY SWEATY AND WARM. PATIENT BECAME ALERT AGAIN. EYES OPEN, SPEECH SLURRED. EYES ROLLING. UNRESPONSIVE TO NAME AGAIN. PT VOICED, "I CAN NOT SEE". PT SWINGING ARMS, CRYING, AND STUMPING FEET ON THE FLOOR BUT NOT RESPONSIVE TO NAME. PT ALERT AGAIN. NOT ANSWERING TO NAME BUT VOICING, "I HAVE TO THROW UP." PT VOMITED MODERATE AMOUNT OF YELLOW SUBSANCE. PT UNRESPONSIVE AGAIN. COOL TOWEL PLACED TO PT HEAD. SPIRITS OF AMMONIA PLACED UNDER NOSTRIL. PT RESPONSIVE SHAKING HEAD. PT BECAME WEAK AGAIN. PT ASSISTED TO FLOOR. B/P 110/72. PULSE 72. INFORMED SCHOOL TO CALL PARENT AND 911. STAFF REPORTED MOTHER ON HER WAY BUT 911 CANCELLED. PT VOICED ONLY EATING MARSHMALLOW TREAT THIS MORNING. PT REMAINED ALERT. PEANUT BUTTER WITH JELLY GIVEN. PT CONTINUED TO SIT UP TALKING. LEFT WITH PARENT TO GO TO CLINIC TO BE ASSESSED BY DR.  SPOKE WITH CLINIC DR. ABOUT EPISODE AND VACCINES GIVEN. DR. VOICED MAY HAVE BEEN PATIENT APPREHENSION WHICH THEY SEE WHEN ADOLESCENTS RECEIVE SHOTS. MAY HAVE BEEN MENACTRA BECAUSE THEY USUALLY HAVE PT TO LIE DOWN FOR 30 MINUTES AFTER RECEIVING MENACTRA. STAFF SPOKE WITH MOTHER AFTER DR. VISIT. MOTHER VOICED DR. STATED IT WAS THE HPV VACCINE. PATIENT WAS FEELING OKAY. RECOVERED.
Mom reports child developed night terrors and feels it is due to DtaP. Had first night terror night vaccine given, has had one again 2 other times when I spoke to mom again
Two weeks after receiving mumps vaccine, the patient developed mumps virus. No further info is available.
Arm from top of shoulder to elbow is very swollen, hot, painful, itchy. Swollen Glands,   We have pictures, wont let them load
Information has been received from a liscensed practical nurse concerning a 37 months-old white female with a severe peanut allergy and a history of bronochospasms who on 03/22/99, at one year of age, was vaccinated subcutaneously with the first dose of MMR. On 04/09/01, the pt experienced a 'breakthrough case" of varicella with many lesions. Unspecified medical attention was sought.  The pt's outcome was unknown.
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 75-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15May2023 as dose 5 (booster), single (Lot number: Gj3270) at the age of 75 years, in left arm for COVID-19 immunization; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for COVID-19 immunization. The patient's relevant medical history included: "Degenerative arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: The patient has no known allergies. Treatment of COVID-19 was Paxlovid from 16Sep2023 to 20Sep2023.
left side of neck swollen; neck feels hot; neck hurts to the touch; bad headache; A spontaneous case report sent by a other non-healthcare professional on 19-JAN-2021, concerning a 62-year-old Female who received Moderna's COVID-19 vaccince (mRNA-1273) experienced bad headache, neck swollen, neck feels hot and neck hurts when touched.  The patient medical history was not provided. No relevant concomitant medications was reported.  On 16-Jan-2021, the patient received first dose of Moderna's COVID-19 (mRNA-1273) (Lot number: 027L20A) Vaccine on left arm.  On 17-Jan-2021,the patient developed bad headache. On 19-Jan-2021, when patient woke up she experienced  left side of her neck swollen, neck feels hot, neck hurts when touched.  No treatment information was provided. The action taken for Moderna COVID-19 Vaccine (mRNA-1273) was unknown.  The outcome of the events for - bad headache  Unknow, neck hurts to the touch - Unknown, neck feels hot - Unknown, left side of neck swollen  Unknown.
Information has been received from a health professional concerning an 18 year old female who on 11-JUL-2007 at 11:00, was vaccinated IM into the right buttock with a first 0.5ml of Gardasil (Lot # 657005/0314U). There was no concomitant medication. On 11-JUL-2007 the patient experienced dilated pupils and she turned white. The patient fainted for approximately 30 seconds. A minute after being conscious, she passed out again but for a shorter period of time. Subsequently, the patient recovered. Additional information has been requested. This is in follow-up to report (s) previously submitted on 8/14/2007. On 11-JUL-2007, the patient recovered. Additional information is not expected.
Anemia - ED visit and hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
On 10/07/2015, I received the GSK-FLUARIX quadrivalent flu vaccine at 1430.  Lot number 43E97-expiration 6/30/2016, NDC # 58160-903-52; this was obtained from a box received at the same time as the box from which my vaccine came.  I was the first to receive the vaccine, and the box was used in its entirety by other co-workers who have not reported any side effects so far.  The box for my exact vaccine was disposed of prior to realizing my reaction might need follow-up. At 1435, I started to feel a tingling sensation around my lips.  I was at work, where I had received the vaccine provided by the employer, and administered by a nurse on my unit.  I stayed with the other nurses for 15 minutes, and while the symptoms were not getting better, they were not getting worse, so I went home.  I took 50 mg diphenhydramine (Kirkland generic), Allegra-D 60/120 mg and Zantac 150mg, knowing that these were similar medications I had received for an allergic reaction to Keflex in 2011.  The symptoms lessened slightly after taking these medications. I saw a member of the employee health staff at 1630, and she advised me to be seen in the ED at our hospital.  At 1830, I did go to the ED.  My symptoms at that point were a slight worsening of the tingling around the edge of my lips and itchy eyes.  I did not feel short of breath, however, I could tell the OTC anti-allergy/anti-histamine medications were not going to be enough to relieve the itching.  They loaded me with prednisone 60 mg and sent me home on a prednisone taper. The peri-oral and eye itching continued until about midnight.  10/8/2015 at 0500 I took prednisone 60 mg, diphenhydramine 25 mg, loratadine (CVS generic) 10 mg and Zantac 150 mg, which all worked well to keep my symptoms to a minimum of oral and eye itching.  Since approximately 1600 10/8, or just over 24 hours post exposure, additional diphenhydramine 25mg, Allegra-D 60/120 mg and Zantac 150 mg is ineffective at relieving the itching.  Beginning at approximately 2100 10/8, the itching had spread to the entire body, most notable on scalp, ears and then somewhat on trunk and extremities. There is no rash or swelling of lips or eyelids at this time, just the pruritis. Friday, October 09, 2015, I returned to see a physician, and he provided me with a prescription for ondansetron 4-8mg ODT every 8 hours as needed for itching to replace the Zantac 150mg of which I took the first dose at 1700 today.  The itching continues, primarily of the face, scalp and neck, but still no rash.   As a nurse, I have received the flu vaccine provided by my employer for the past 10+ years, and I have never had a reaction in the past.  This is the first year I have received the GSK-FLUARIX quadrivalent, as my employer was unable to obtain it last year, but I did receive the FLUARIX trivalent in 2014, according to the employee health department records.
About 4 hours aftr receiving the vaccination pt reports whole arm became red and warm and he felt his throat become itchy and it was more difficult to breath. He states he did not receive any treatment or care because symptoms decreased over the next few hours and returned to normal by the next day
Sore at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore at injection site) 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.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore at injection site). At the time of the report, VACCINATION SITE PAIN (Sore at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Double pneumonia; A spontaneous report was received from a consumer (daughter of the patient) for a female patient of an unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and who developed double pneumonia.  Patient had heart problems. No concomitant product use was reported.  On 03- Feb-2021, the patient received their first dose of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On an unknown date the patient developed double pneumonia. Patient was hospitalized on 26-Feb-2021.   The reporter believed the hospitalization had nothing to do with the vaccine. She was just concerned about re-scheduling the second vaccine appointment.  Serious ness criteria: Hospitalization   Treatment information was unknown.  Action taken with mRNA-1273 was unknown.  The outcome of the event of double pneumonia was unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
He got his vaccine, started complaining of pain on his legs.  She took him home and he continued to complain and mom gave him Tylenol and Motrin for pain.  He continued to complain and you called his pediatrician and told her that he was still complaining of pain and felt that he may have been just sore, but felt that something else was going on and that it was progressing too fast.  He did not want to walk due to the pain on it, which radiated to the other leg.  He was crying all the time and complaining of the pain and said that he could not feel his legs.  She took him to the ER on 12/27/21, and they were pocking his legs and he did not have any reaction to that.  They felt that he needed to be seen by a neurologist and other doctors and he was admitted.   Multiple doctors came and saw him and they were in agreement that he had Guillain Barre and had a spinal tap.  They gave him IVIG for the entire time he was in the hospital.  He was in the hospital 6 days and the IVIG helped.  After that he went to rehab for 2 days, he is supposed to be getting OT and PT, as well as seeing a cardiologist.  He complains of chest pain and states that his heart goes really really fast.  He gets fatigued easily.   He is very wobbly and overall has weakness on his body from this.  He was a very active child, and now has the movement of an 80-90 year old man.