chrisvoncsefalvay/vaers-outcomes huggingface dataset:
adult dose was administered to a pediatric female patient; adult dose was administered to a pediatric female patient; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 15-day-old female patient who received HBV (Engerix B adult) (batch number KM72C, expiry date 18th June 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th July 2021, the patient received Engerix B adult and Engerix B Pre-Filled Syringe Device. On 15th July 2021, unknown after receiving Engerix B adult and Engerix B 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 nurse reported that an adult dose of Engerix B was administered to a pediatric patient, which led to overdose and adult product administered to child. The reporter consented to follow up.
Exhaustion, joint pain, fever, disorientation, diabetes and blood pressure uncontrolled. She visited an emergency room at another institution and was hospitalized. A week later she visited our emergency room and was also hospitalized with hypercalcemia dx, altered mental status.
After shots on 1/9/01, unusually intense crying for less than 3 hours. Fever, acted as though not well, for the next 3 days. Frequent bouts of crying, increase in spitting up and projectile vomiting, small amounts of bloody mucus in stool. Did not sleep for more than 1 hour at a time. On 1/13/01, had rapid breathing during nap, stopped breathing. I picked him up and patted his back, he took a few breaths and then stopped, went limp, eyes rolled back and his head rolled. Regained consciousness in 10 seconds. That night he slept for 8 hours and the next night he slept for 9 hours. He seemed his normal self again about 2 weeks, post vax.
Information has been received from a registered nurse and a health care professional concerning a  13 month of old white male who on 10/26/01 was vaccinated with a dose of MMRII. Concomitant vaccination the same day included Varivax. On 11.01.01, the patient was seen for a rash diagnosed as rash secondary to MMRII, also described as hives reaction. The RN reported that the patient has no systemic symptoms. No therapy was prescribed. Subsequently on 11/06/01, the patient recovered from the hives. No further information is expected.
Patient was provided the pfizer 12+ vaccine rather than the pedicatric pfizer vaccine (5-11 yrs). Patient's mother was contacted by the provider that administered the vaccine (on 06.23.22). Mother stated that the patient is doing fine and hasn't had any side effects to report at this time.
Shot on the 22nd of January. Hives started on the 27th. Took Benadryl. It was gone by the 30th. The 2nd shot on the 19th of March. A very sore arm, a slight fever (100.4 degrees), tiredness lasted until the night of the 20th of March. Took Tylenol at 6pm on the 19th of March. I felt well in the morning of 21st.
Localized red and painful, lasted for more than 2 days (redness starting to get better @ day 4).
Dry throat, slight tightening,  hard to swallow, headache. I had to sit there for another 30 minutes.  They took blood pressure and checked pulse.
Pfizer-BioNTech COVID-19 Vaccine EUA: patient hospitalized for COVID-19  pneumonia and subsequent pulmonary embolism. Administered oxygen,  remdesivir, steroids, anticoagulation. Patient improved and was discharged to home medically stable on oxygen and anticoagulation. On outpatient follow-up continues to improve.
Pt reports total body generalized weakness for the 6 hours after he got the COVID-19 booster.  He then had a ground level fall and was unable to get up.  Pt reports that the shot was given on 11/10, however the vaccine registry states it was given on 11/9.
Pain occurred at the time of the injection (this did not happen with first vaccination). A knot at injection site about the size of a sweet pea. The site is warm to the touch and very itchy. I feel out-of-sorts. Kind of tired and listless. I did not sleep at all last night (4/21pm-4/22am). My stomach is slightly upset. No vomiting at this point. My temp is 99.0 f. I am suddenly forgetting words. The word I heard or thought about a few minutes or seconds ago is just gone. Completely. This is unusual for me and is VERY concerning.
Temperature excursion; This spontaneous report was received from an office manager and refers to a 12 month old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 29-JUL-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # S004554, expiration date 14-FEB-2021 (formulation, strength, exact dose and route of administration were not reported) for prophylaxis. The temperature excursion was reported as: temperature range of 6 degrees Fahrenheit (F) to 14 degrees F for 80 hours. There was no previous temperature excursion. A data logger was used to capture the temperatures. The outcome of the event was unknown.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2009USA007311: US-009507513-2009USA007316: US-009507513-2009USA007304:
No adverse effects.; a patient was administered an improperly stored VARIVAX.; This spontaneous report was received from a medical assistant referring to a patient of unknown age. Information about pertinent medical history, concurrent condition and drug reaction/allergy was not provided. The patient's concomitant medication included sterile diluent.   On 06-JUL-2019, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (lot # R003299 with expiration date 01-FEB-2020; strength, dose detail and route were not reported) for prophylaxis(improper storage of product in use). The sterile diluent used to reconstitute the vaccine was stored properly. The vaccine underwent temperature excursion from 15 Fahrenheit degree to 46 Fahrenheit degree for a duration of 3 hours. There was no previous temperature excursion. A digital data logger was not involved. No adverse effects was reported. The outcome of the event was unknown. The causality was not provided.
Skin painful to touch approximately 12 hours after receiving acclimation. This reaction last approximately 18 hours
Body Malaise; Aches and pain; Fever; This case was received via United States FDA VAERS (Reference number: 909064) on 18-Jan-2021 and was forwarded to Moderna on 18-Jan-2021.    This spontaneous case was reported by a health care professional and describes the occurrence of MALAISE (Body Malaise), PAIN (Aches and pain) and PYREXIA (Fever) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0262201A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 24-Dec-2020, the patient experienced MALAISE (Body Malaise), PAIN (Aches and pain) and PYREXIA (Fever). At the time of the report, MALAISE (Body Malaise), PAIN (Aches and pain) and PYREXIA (Fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 101.3 101.3.     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 information was not provided. Concomitant information was not provided.
2cm x 4 cm red, tender nodule on tricep. Almost bruised appearance 7/4/07 left arm
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date the Vial was placed in Refrigerator : 18-NOV-2021  No Concomitant Medications were provided by the Reporter      No Treatment Medications were provided by the Reporter
Extreme swelling in the spinal column; This is a spontaneous report from contactable consumer reported for the patients mother via Pfizer. A female patient of an unknown age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch number and expiry date were not reported) via an unspecified route of administration on 18Feb2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. On 26Feb2021 the patient experienced extreme swelling in the spinal column. The patient hospitalized on 26Feb2021. The patient was transferred to an educational facility with more doctors and staff. The reporter wanted to confirm if there was any information from Pfizer that can help the medical doctors of his mother. The outcome of the event was unknown.
Co-worker reports "On 07/09/21 woke up with a fever, chills, muscle aches, fatigue. On 7/10/21 woke with no fever but minor aches, pain and fatigue. was doing light chores and suddenly had severe chest pain and shortness of breath. Felt like she couldn't "catch" her breath and someone was squeezing her lungs and heart. Went to bed and continued to hurt throughout the night 7/11/21. continued to have shortness of breath and intermittent but severe pain. On 07/12/21 spoke with cardiologist and had a stress test and echocardiogram sue to pain (normal). As of 07/20/21 continues to have intermittent chest pain but less severe compared to when it first started. Struggles with shortness of breath very quickly when taking stairs that she did not have previous to vaccine."
3/6/21 5:07am, woke with red, swollen face like a shellfish allergy reaction. Top of chest right below neck was red. Face and red area of chest itchy. Went to quick care, received steroid injection and prescriptions for hydroxyzine and prednisone.
Swollen lymph nodes under left armpit after first dose and still remain over a month later. Swollen armpits under right armpit and chin/ neck, exhaustion, and brain fog after second dose and still remain about two weeks later.
fever, chills,  vomiting, myalgia, headache,  abdominal cramping and pain
My kid reported both jaws pain in early morning on 8 July and he woke up with pain. I gave him Ibuprofen 200 mg 1 tablet after 1-2 hrs he feel relaxed. He got first dose of Pfizer vaccine on 6th July at 2 30 PM at Kroger Pharmacy
new daily persistent headache that started 4 hours after 2nd Moderna vaccination and continues with persistent symptoms through 3/24/2023.  First Moderna vaccine was on 03/17/2021 without adverse effect.  Associated neck pain, fatigue, dizziness/unbalance.  Has been on nortriptyline 10 mg and magnesium 400 mg and CoQ10 300 mg since October 2012. Increased to 20 mg in early March 2023 with now some improvement in headaches/symptoms.
This spontaneous report was received from a medical assistant and refers to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M017983. No adverse effects were reported. The digital data logger was involved in recording the temperature excursion. This is one of six reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA005166: US-009507513-1708USA005167: US-009507513-1708USA005169: US-009507513-1708USA005170: US-009507513-1708USA005168.
5x7.5 cm area of redness and induration developed 2 days after shot. Treated w/warm compresses. The follow up states problem in Rt thigh-no reaction to flu.
Information has been received from a licensed practical nurse referring to a 15 years old female patient. The patient had no pertinent medical history, drug reactions/allergies nor concomitant medications. On 23-SEP-2016, the patient was vaccinated with her first dose of GARDASIL 9 (0.5 ml, lot # L036301, expiration date 20-DEC-2017) intramuscularly in the left arm. On the same date, the patient received FLUZONE in the right arm. On 25-SEP-2016, the patient experienced pain at the GARDASIL 9 injection site. On 25-SEP-2016, the patient experienced redness and swelling at the GARDASIL 9 injection site, which had not resolved but had not worsened. On 28-SEP-2016, the patient experienced swelling and numbness of the right upper lip, which resolved after 24 hours (29-SEP-2016). No treatment was given for the events. No laboratory test was performed. The outcome of the event pain at the GARDASIL 9 injection site was unknown. The causality between GARDASIL 9 and the events was not provided. Additional information has been requested.
pt recvd vax 27APR93 & on 12MAY93 began vomiting & diarrhea; following day devel congestion & fever 102.5; 16MAY taken to ER blood cutlure pos for H. influenzae type B; treated w/Ceclor, Rocephin;
On advice from my physician at my annual physical in September 2017 I went for my Shingles shot since I turned 60 in August. Started out the day great, had both the flu shot (also suggested I get) in one arm and the Shingles shot in the other. Awoke next day, arm was three times its normal size and painful. Area was red and continued to grow red then to pink on the outer edges until it reached my elbows. Two day later I began having headaches (and I don't get headaches like this) and couldn't sleep at night! Used ice compressed and took TYLENOL but the symptoms did not dissipate until just today (one week and one day after initial shot). Received the shot at the Pharmacy.
vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients; No Adverse Event; 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients) and NO ADVERSE EVENT (No Adverse Event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients).    No concomitant medication was provided by reporter. Nurse reported an adverse event 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients are involved, date of administration 11Jan2023, lot numbers unknown to the HCP.  No treatment medication was provided by reporter. Sender's Comments:  MODERNATX, INC.-MOD-2023-697850:Master case  MODERNATX, INC.-MOD-2023-697852:Master case  MODERNATX, INC.-MOD-2023-697849:Master case MODERNATX, INC.-MOD-2023-697851:Master case
mom reports lethargy & droppy lt eye lid;no significant ptosis noted upon exam & dx w/lethargy secondary to vax rxn
Rash start on left arm (underside) and spread to right arm, front torso and both upper front legs. Had some minor hot flashes and chills as well. No itching. Patient took BENADRYL and was instructed to take more as needed. Also seek medical attention if condition became worse or didn't improve in the next day or 2.
Woke up to rapid heart beat (114 bpm), my normal resting heart rate is between 59-75 bpm.  Heart stayed elevated for an hour and continued to be higher than normal throughout the day.  Arm was excessively painful and hot, with minor swelling.  After 24 hours, a dose of ibuprofen was taken and relieved the pain, heart rate continued to be elevated but lingered around 90 bpm.
Vaccine expired on 8/31/2022 and was given on 9/01/2022
Patient was given actHib mixed incorrectly. ActHib was inadvertently mixed with sterile water instead of the saline. No adverse reaction noted from patient.
after first dose, very mild side effects like body aches and stomach upset; after first dose, very mild side effects like body aches and stomach upset; This is a spontaneous report from a contactable consumer (patient herself).  A 39-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247; Expiration Date: May2021) via an unspecified route of administration on 17Jan2021 as DOSE 1, SINGLE (age at vaccination was 39 years old) for covid-19 immunisation. Medical history was none. There were no concomitant medications. On an unknown date in 2021, after first dose, patient experienced very mild side effects like body aches and stomach upset that subsided within 36 hours. The outcome of both the events was resolving.   Follow-up attempts completed. No further information expected.
Stabbing pain in left eye lid, progressive pain & then visual disturbance resulting in acute optic neuritis 4 days later. Total loss of vision, pain.
This spontaneous report as received from a nurse refers to unspecified amount of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date these unspecified amount of patient were vaccinated with a dose of GARDASIL (lot number H017698 expiration date 02-JUL-2015, dose, route not reported) that underwent a temperature excursion. Concomitant medications were not provided. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Numbness on Face, Jaw and Lower Lips; Dizziness; Felt sleepy; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness on Face, Jaw and Lower Lips), DIZZINESS (Dizziness), SOMNOLENCE (Felt sleepy) and HEADACHE (Headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to vaccine (Allergy to flu vaccine) and Egg allergy.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced HYPOAESTHESIA (Numbness on Face, Jaw and Lower Lips), DIZZINESS (Dizziness), SOMNOLENCE (Felt sleepy) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 01-Mar-2021, DIZZINESS (Dizziness), SOMNOLENCE (Felt sleepy) and HEADACHE (Headache) had resolved. At the time of the report, HYPOAESTHESIA (Numbness on Face, Jaw and Lower Lips) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.
7/3 Fever of 102F 7/4 Fever, rash, and red bumps 7/5 Fever and rash (red bumps gone) 7/6 Rash only (fever gone) 7/7 Still has rash and seems to be spreading
crying throughout the day, about 655PM turned blue, limp-didn't appear to breath; transp to hosp; in hosp to 1130PM;
On 1/6/03 mother reported that the day after receiving Prevnar X 1 wk, patient had a red knot and pain to LAT.  Mother stated knot went away after one week
after the injection, I couldnt breathe and colapase in the waiting area and my pulse was low was taken to the er