chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On completion of flu injection she passed out and rolled out of chair hitting head on concrete.  She quickly regained consciousness.  She had not eaten and was given crackers and sprite.  No injuries noted.
About a day after I received the vaccine, I experienced flu-like symptoms and a low-grade fever. At the same time, painful, burning blisters appeared on my hands and on my right lower leg.
A report has been received from a Health Professional concerning an 11 year old, male subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (Intranasal) started on an unknown date. It was reported that the patient experienced three patients inadvertently received FLUMIST QUADRIVALENT which started on 04-Dec-2014. The outcome of the event of three patients inadvertently received expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
influenza vaccine vaccine High dose for 65 and over given instead of  Influenza vaccine for 18-64.
Student is 17 years of age and that was overlooked when administering the vaccine.  After administration it was seen.
Uncontrollable crying, complaining that he can't move, headache, won't walk and fever of 101.
State night of 1/7/14, had high-grade fever, malaise. After several days went to ER was dehydrated and diagnosed with "flu" not covered by flu shot. Told ER received flu shot same day as "got sick". Received IV antibiotics in hospital. States hospital informed D/T egg allergy - should not have received and to let this nurse know of adverse event. Denies hives, chest tightness, throat swelling. States last "a couple of weeks".
Initial and follow up information has been received from a physician concerning a 5 month old female who on an unspecified date, was vaccinated with the first dose of PedvaxHIB  (Lot# 652226/0655R). It was reported that the patient's mother had requested to wait and vaccinate the patient with PedvaxHIB at the 5 month visit. It was reported that the patient was well at the time of vaccination and did not received any other concomitant vaccines on the day of vaccination with PedvaxHIB. On an unspecified date, the child developed an "unusually severe reaction" involving "high fever", "inconsolable crying," "red lumps at the injection site" and " a sore at the injection site". On an unspecified date, the patient recovered from the events. It was noted that a twin sibling had a similar experience following vaccination with PedvaxHIB, (WAES#0601USA01931). The physician checked with parents of the other children vaccinated with this lot number and they were fine. A lot check of concern has been requested. The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. In addition, a review of the Quality control Quarantine/Rejection System that there were no open Quarantines registered against this lot/fill. No further information is available.
Immunization administered at 1421 and patient left facility shortly after with grandfather and brother who accompanied her to appointment. Mom called at 1446 reporting that her child was experiencing hives on her face.  Nurse told mom to administer Benadryl and to monitor for trouble breathing or worsening hives and at that point to call EMS or go to the nearest emergency room.
45 minutes post Seasonal Flu vaccine, neck started itching (about 0955 AM); @ 13 30 Arms, neck, head, face, eyebrows itching - red blotches. At 1400 BENADRYL 25mg po @ 1430 PEPCID 20mg. At 1600 better, only itching left between shoulder blades.
Administered a dose of Quadracel to a 21 month old; Initial information received on 24-Mar-2020 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 21 months old patient who was administered a dose of  DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (Inappropriate age at vaccine administration).  Medical history, medical treatment and family history were not provided. Patient previously recieved 3 doses of TDAP vaccine.   Concomitant medication included Hepatitis A vaccine.  On 20-Mar-2020, the patient visited the doctor and patient received a fourth dose of 0.5 ml of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot C5497AA) (expiry date: 17-Jul-2020) via intramuscular route in the right thigh for prophylactic vaccination.  It was a case of an actual medication error due to Inappropriate age at vaccine administration.  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 and Module VI of the 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
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Sep-2021 at 2:40 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 24-Sep-2021 at 2:40 PM, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not provided.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Patient did not have any adverse events and did not require any medical attention. no problems reported from patient. Treatment information was not provided.
Feeling like something is crawling on my skin all over my body, hands and joints swollen, restlessness/ insomnia  Chest hurting Face burning  Irritated Mood swings  Clenched jaw/grinding teeth Short fuse temper  Aggression  Stupid  shot I didn't want in the first place stupid labor laws...j have to get a shot to be considered for hire at some places.
Left shoulder pain and decreased ROM after vaccine which has progressively worsened even with supportive care.
Dizziness, loss of consciousness, fell on his face, hit head, pale, diaphoretic, memory loss x 2 hrs. Then nausea and vomiting, malaise, weakness, headache until the next day. Both arms very sore. Contacted emergency room nurse and hospital nurse supervisor about reaction. For advise, family physician called.
According to the caller, it makes everything better. It helps his numbers in his condition better. He added that after his previous Moderna COVID 19 shots, it has positive impact in his laboratory numbers. He would like to report it to Moderna.; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (According to the caller, it makes everything better. It helps his numbers in his condition better. He added that after his previous Moderna COVID 19 shots, it has positive impact in his laboratory numbers. He would like to report it to Moderna.) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (According to the caller, it makes everything better. It helps his numbers in his condition better. He added that after his previous Moderna COVID 19 shots, it has positive impact in his laboratory numbers. He would like to report it to Moderna.) and NO ADVERSE EVENT (No adverse event). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (According to the caller, it makes everything better. It helps his numbers in his condition better. He added that after his previous Moderna COVID 19 shots, it has positive impact in his laboratory numbers. He would like to report it to Moderna.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Reporter reported it makes everything better. It helped his numbers in his condition better. He added that after his previous Moderna COVID 19 shots, it had positive impact in his laboratory numbers.   Treatment information was not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-Sep-2023: Live Follow-up information received included no new information.
The morning after my vaccine, 08/31/2021- my arm was swollen and did not feel good.  I had a scratchy sore throat.  I felt like I was coming down with a  real bad cold-- body aches, muscles aches, and later on a fever. Then I had chills and everything you feel when you have a bad flu. All these symptoms lasted for about 5 to 6 days. I had a telehealth appointment on 09/06/2021.   They said it sounded like I had developed a sinus infection again from the symptoms. They prescribed me an antibiotic- generic for Augmentin.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 07-MAR-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength: 0.5ml) (lot # L036245, expiration date 09-FEB-2018). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion for three times. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (refrigerator/freezer) (R/F) for the first and second time were 48, 34 and R; 16, 29 and R. The total cumulative excursion time (hour), the highest recorded temperature (Fahrenheit degree) and the type of excursion (refrigerator/freezer) (R/F) for the third time were 24, 49 and R. The storage criteria was R. This is one of several reports received from the same source. Additional information has been requested.
Patient had generalized tonic clonic seizure lasting approximately 5 seconds a few minutes after receiving GARDASIL #1. This was followed by dizziness, diaphoresis, sore throat & headache. Patient may have hit head against wall during the seizure.
Rapid onset polyneuropathy in feet, legs, hands, arms, mouth/lips/tongue; severe unintentional weight loss; extreme weakness, muscle atrophy, chronic neuropathic pain; fatigue; cognitive delay; nausea; heart palpitations; reactive lymph nodes, muscle twitches; aggressive progression of small fiber neuropathy; dizziness; blurred vision; with symptoms continuing.  Treatment and tests by multiple physicians including Internal Medicine, Neurology, Pulmonary, Cardiology, GI and Infectious Disease and two inpatient hospital stays at 2 specified hospitals.  Current treatment includes Remicade and IVIG infusions, prednisone, methotrexate to suppress immune system and prevent further nerve damage. Continuing care at hospital and another clinic in a different state, with physical therapy, pain management, limited mobility. and work disability.  Prognosis uncertain.
Information has been received from a medical assistant concerning a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with a dose of improperly stored PEDVAXHIB (dose and route not reported, lot # L042257 and expiration date 17-AUG-2018). The vaccine was exposed to 25.7 F for 1 day, 21 hours and 41 minutes. No previous temperature was reported. No adverse effects were reported. Additional information has been requested.
Patient came into clinic for a covid bivalent booster and was given the  covid monovalent vaccine instead. Privacy contacted, states no adverse reaction to the patient,  can have the bivalent booster in 2 months per Pfizer policy. Patient called and notified, voices understanding.
/P vax pt had T 101, as of 11Jun90 diarrhea X 2 wks, body rash & swollen ears & eyes, /w stomach cramps
flu 2wk p/vax treated w/ Keflex & decongestion 22OCT97; 1 wk later went to ER treated w/Biaxin & duratuss;saw MD 2 days later as follow up treated w/theophyllin, cough med, cyndal HD, vit C & herbal vitamin 7NOV97 still sx fatigue 8DEC97;
pt was a non-responder p/6 doses of Hep B vax; 1st 3 doses were unk vax brand; 2nd 3 doses were Engerix-B;
no adverse event; HCBP calling to report AE for patient that received dose of expired PNEUMOVAX 23.  Vaccine expired on 8/18/2023.  Per memo, data supports dosing.  No additional AE or PQC.; This spontaneous report was received from Other Health Professional and refers to an 81-year-old male patient. The patient's medical, concurrent conditions and concomitant therapies were not reported.  On 30-AUG-2023, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) injection, single dose, lot #U035117, expiration date: 18-AUG-2023 (strength, route of administration, and indication were not provided). No additional adverse event was reported.
Red, swollen, hot skin at injection site- approx. 4cm~ Left deltoid.
1/9/2021 - at 10:10am I experienced my first-ever episode of dizziness.  If I had not gotten on the floor I would have fallen on the floor.    Then broke out in a whole body sweat.  I stayed on floor for about 4-5 minutes.   I did not lose conscience.  Then went to sit on recliner.  Felt a twinge of nausea.  After 2 hours I got up and felt okay.
Narrative: Patient Felt itching around vaccination site a few minutes after  receiving 1st dose of pfizer covid vaccine. Also C/O nausea. 10:37 VS  BP;148/86. P 67, PO2 99%. Alert and seated in no distress. Some erythema in  upper left arm around vaccination site. Nausea resolved and patient released at  10:56 with instructions to see medical care at Ed if symptoms worsen.
Patient was given refrigerated Moderna that was expired beyond it's 'Beyond Use Label' date of 01/27/2022.  Vial was placed into fridge on 12/28/2021.  Vial was not removed from fridge in time for 'Beyond Use' expiry date and inadvertently administered.  Manufacturer's expiry date is March 25, 2022.  Provider informed.  Moderna informed and stated that 'the vaccine administered on January 28 to February 7, 2022 from lot number 033H21A maintained the activity necessary to protect against the SARS-CoV-2 (covid 19) virus at time of administration'.  Patient called to inform of adverse event x 2, but unable to reach patient.
h/a, nausea, diarrhea, redness & swelling @ inject site; sx began next day & lasted 24 hrs; arm swelling lasted 1 wk; APAP only treatment;
1 1/2 hours after immunizations patient had red blotches on face. 10 minutes later mother states his face and ears appeared swollen and he had hives all over his body. Mother took him to the emergency room where they gave him BENADRYL. The emergency room monitored him until swelling and hives were gone.
Staggered to her car; Severe dizziness; Fell asleep; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Staggered to her car), DIZZINESS (Severe dizziness), SOMNOLENCE (Fell asleep) and FATIGUE (Tiredness) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced GAIT DISTURBANCE (Staggered to her car), DIZZINESS (Severe dizziness), SOMNOLENCE (Fell asleep) and FATIGUE (Tiredness). At the time of the report, GAIT DISTURBANCE (Staggered to her car), DIZZINESS (Severe dizziness), SOMNOLENCE (Fell asleep) and FATIGUE (Tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications was not provided by the reporter.  N o concomitant medications was provided by reported.   This case was linked to MOD-2021-092484 (Patient Link).
Shaky, swollen tongue, weakness, paramedics treated for allergic reaction and stroke, transported to hospital by ambulance.
Patient self reported feeling hot, nauseated, and with headache that evening.  Following day, patient self reported temp of 101 degrees, headache and muscle ache.  By 8 pm on 10/11/2014 symptoms had abated.
Information has been received from a registered nurse referring to multiple patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medication were not reported. On 01-AUG-2016 the patients were vaccinated with improperly stored (at 10.4 degree centigrade for 6 hours and 17 minutes) GARDASIL 9 (lot # L026602, expiration date 19-OCT-2017, dose and route unknown). There was no temperature excursion previously. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
A non-serious spontaneous report of accidental exposure and headache has been received from a female medical assistant (date of birth 01-May-1969) concerning her own experience subsequent to administering FLUMIST.  Medical history included migraines.  Concomitant medications included levothyroxine, duloxetine hydrochloride, cetirizine hydrochloride, and montelukast sodium.  The patient did not take medication for her migraines.  The medical assistant never received FLUMIST.  When the medical assistant administers FLUMIST to a patient or walks into an exam room where FLUMIST was administered, she develops a headache across the top of her forehead.  She described them as mild, they "are not migraines", and the headache last until she goes outside away from where FLUMIST is being administered.  She indicated that it did not matter if she administered FLUMIST first thing in the morning or not until the middle of the afternoon, she always got a headache from it.  She experienced no other symptoms.  The medical assistant did not treat the headaches because they always resolved as soon as she went outside. Required follow-up attempts have been performed, requested information unable to be obtained.
Patient first dose PFIZER was given 3 Nov 2021, Patient received 2nd dose PFIZER 17 Nov.  did not meet the 21 day criteria for his 2nd dose.
After receiving his second vaccine, he complained that he was having a headache, a stomach ache, and ?not feeling good?. Went to the hospital on 03/20/2021 complaining of worsening pain and the hospital only treated him for a UTI with antibiotic, altough his platelet count was low (was unaddressed). After being released two days later, he became delirious and then starting throwing up blood, having a nose bleed, and throwing up his feces. They put him on the vent, tested him for Covid 3-6 times (all negative), and then diagnosed him with a brain hemorrhage that later led to a massive stroke. They diagnosed him (tentatively) with TTP due to low platelet count, however upon informing the doctor of him recently being vaccinated, she stated it could have been ITP, however she did not report this adverse effect.  This doctor was in the ICU at hospital.
Moderna arm; can we chat about this Moderna arm its no joke super itchy; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE REACTION (Moderna arm) and VACCINATION SITE PRURITUS (can we chat about this Moderna arm its no joke super itchy) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Moderna arm) and VACCINATION SITE PRURITUS (can we chat about this Moderna arm its no joke super itchy). At the time of the report, VACCINATION SITE REACTION (Moderna arm) and VACCINATION SITE PRURITUS (can we chat about this Moderna arm its no joke super itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  No treatment information for the event was provided.
Infant had blood transfusion 5/17/01 received MMR and varicella 3/13/02. Infant broke out in a macular red rash covering trunk arms and thighs 3/27/02. Had a fever or sick contacts prior to rash. Rash rechecked on 4/4/02-faintly present. Child in registry twice with two different birth dates. NOte in one file that child had transfusion and that MMR should not be given until 4/19/02. The second record was complete and had no notation. On screening questionnaire mother marked that the child had not had a transfusion in the past 11 months. Live vaccine given at HD. Provider called about duplicate records in computer. Records have since been combined and duplicate record deleted.
two doses before adequate time elapses; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA653A, expiry date 28th February 2023) for prophylaxis.   In July 2022, the patient received the 2nd dose of Menveo. In July 2022, unknown after receiving Menveo, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date: 27-Jul-2022 Reporter's comment: The nurse reported that two patients received early second dose with unknown details, while only one patient had an incorrectly reconstituted dose administered. 3 patients were vaccinated with the same lot so the reporter was asking what happened if a patient receive two complete doses of Menveo .  All patients were vaccinated on July 2022. No more information regarding patients were available at the moment, clarified by both agent and the reporter. The reporter consented to follow up. The case is for 1 of 3 linked patients, reported by same reporter. Additional supportive information: The patient received second dose earlier than the recommended interval, which led shortening of vaccine schedule.; Sender's Comments:  US-GSK-US2022111770:Same reporter US-GSK-US2022AMR112790:Same reporter
Within 24 hours patient had spiked a fever of over 100. He became lethargic, nearly unresponsive though awake. His face/body began to swell and he showed difficulty in breathing. The swelling and difficulty breathing resolved within a couple of hours. The fever decreased with Motrin and resolved about 48 hours after vaccination. Prior to this vaccine patient had been vocalizing frequently and even made distinguishable words (a happy surprise for a 5-6 month old). In the weeks after the vaccine his vocalization/speech decreased and became minimal by 8 months, at which time we offered spiraling as a supplement. Within 12 hours he began vocalizing again. We're waiting on his speech to return  and continue developing.