chrisvoncsefalvay/vaers-outcomes huggingface dataset:
medication error due to ADACEL was administered after a temperature excursion that was not supported (with no reported adverse event); medication error due to ADACEL was administered after a temperature excursion that was not supported (with no reported adverse event); Initial information was received on 10-May-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 8 years old female patient who reported medication error due to DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] was administered after a temperature excursion that was not supported (with no reported adverse event).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 05-May-2023, the patient received a 0.5 ml dose, Total (once) of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (Suspension for injection) (lot number: U76658A , expiry date: 04-Mar-2025, strength: standard) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient had medication error due to adacel was administered after a temperature excursion that was not supported (with no reported adverse event) (product storage error) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  On 05-MAY-2023 the patient had medication error due to adacel was administered after a temperature excursion that was not supported (with no reported adverse event) (poor quality product administered) same day following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for the event.  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 the 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.
nausea, diarrhea,  dizziness, aches & pains all over body, feeling weird, tired, can't get up, all lasting 3 days
Sore arm and rash 4/9 within 12-16 hours of shot.  Body aches and low fever for 12-24 hours after shot.  Eyelid hives and rash start 4/10 off and on thru 4/22. Saw dermatologist on 4/16. Used elidel 4/10-4/16 was ineffective. Was treated with eucrisa. Somewhat effective but rash clears and returns.  Painful menstrual period 4/22. Unusual at my age and with an  IUD.
The pfizer covid-19 vaccine 12+ gray cap was pulled from the fridge instead of the pfizer covid-19 Bivalent 12+ gray cap vial.  This was not noticed until pharmacist on duty was reporting waste report into the pharmacy computer system and the lot# and vial information did not match the Pfizer Bivalent vaccine.  Patient was called the phone number on file did not work.
not feeding (wouldn't nurse crying for 45 mins gave APAP @ 830; cont to cry; did nurse from 2nd breast but also took bottle; legs are OK from DTP;
G45.9 TRANSIENT CEREBRAL ISCHEMIA 3/29/2023 TRANSIENT CEREBRAL ISCHEMIA
Client came to Health Department on 01-18-19 with complaint of severe body aches that started on the second day after receiving an influenza vaccine. Client received an influenza vaccine on 01-15-18. Client also reports headache and temperature that started on 01-16-19. Client did not take temperature with a thermometer. Client denied having nasal congestion or a cough. Client was referred to PCP. Client return to Health Department on 01-28-19. Client was seen by PCP on 01-19-19. Client had had an EKG done. An appointment was scheduled for client to return to HD but client has not returned calls.
rash on the body (petechiae) caused by some bleeding  in skin (similar to a bruise)
reports a 3 inch in diameter raised, reddened and warm to touch  area to injection site with complaint of itching  Reports no pain or discomfort
fatigue; nausea; chills; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), NAUSEA (nausea) and CHILLS (chills) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced FATIGUE (fatigue), NAUSEA (nausea) and CHILLS (chills). At the time of the report, FATIGUE (fatigue), NAUSEA (nausea) and CHILLS (chills) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information is not provided.  No treatment medication information given.
I received the shot at pharmacy on Thursday and this morning (Saturday)  after being up for a couple hours I suddenly began shaking VIOLENTLY. I dropped a bowl of food and could not get the spoon into my mouth I was shaking so violently, this was a booster shot for covid 19.  The day after the booster I had a slight headache and my arm was sore. I didn?t feel Ill at all..no fever chills..nothing. Besides a light head ache I felt perfect.  My arm wasn?t even sore this morning (2nd day after booster) then out of nowhere I started shaking so hard I dropped my food cause I couldn?t hold onto the bowl. I have never shaken like that in my life. It was like I had no control.  We aren?t talking the shakes?we?re talking violently shaking.  Just thought I might let y?all know. I?m not on any medications.
On 3/26/2021, patient received Moderna vaccine on right deltoid. Patient under age 18. On 4/13/2021, Patient received Pfizer on the left deltoid. Called twice on 6/29/2021. No answer. Unable to leave voicemail. Called on 7/2/2021. NO answer. Unable to leave voicemail. Last attempt to contact made on 7/8/2021. No answer. Unable to leave voicemail.
Severe pain with swollen lymph nodes under left arm arm pit/chest area; gets worse daily and at night. First noticed pain Tuesday morning-very painful and sometimes there is a burning sensation. Injection site/arm pain went away Wednesday night and then returned early Friday morning (today).
a medical assistant gave an expired dose of Menactra; which expired 08May2021 with no adverse event; Initial information was received on 02-Jun-2021 regarding an unsolicited valid non-serious case from a other health professional.  It was reported that a medical assistant gave an expired dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (Suspension For Injection) (lot number: U6575AB, expiry date: 08-May-2021) to a 12 year old female patient on an unknown date via an unknown route for prophylactic vaccination (expired product administered).  It was a case of actual medication error due to expired vaccine used.  Concomitant medication included sodium.  At the time of report, no adverse event 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.
Vaccine log moderna   - 16th, Monday- twitching/spams in injection sight within the first hour of recovering vaccine. Otherwise feeling sore worse throughout day. Could barely undress for bed  - 17th- very sore very painful if touched, or bumped still spasming around injection sight  swelling  - 18th- pretty sore but easing up. Very tiered. Spasm continue near injection sight   - 19th- sore but subsiding a lot. Middle of night arm began going numb, tingling, needle/pin like sensation through arm to fingertips. Alternates between pinky,ring,middle going numb to pointer and thumb, to all. Muscle spams all over body. Anxious   -  20TH very tired. Spasms continue, numbness is off and on but getting stronger. A little sore in injection sight still but not bad. Pin and needle sensation continuing through left arm still. Spasm occasionally in random areas of body. Tiered, mild headache. Called pharmacist she said it is a rare side effect go see doctor if left arm becomes painful or week. Went to emergency room, doctor said come back if I loose strength in arm but could just be ?my normal? response to vaccines.  She said I am swollen and bruised , could be caused by swelling. She also said how the vaccines are new so they just don?t know yet why some people are responding the way they are. Prescribed Benadryl. I told the nurse I was nervous to get my second does and asked if she had advice. Nurse suggested asking to take another brand, I could have misinterpreted her. Also suggested taking Tylenol before second does.    - 21st. Still slightly sore. Spams seem to calm down in the morning but would come back or get stronger throughout day. Feels more like ?vibrating? throughout arm or mild electricity going through it.  Very tiered, feeling depressed and not heard or helped. Mild headache   - 22nd Very depressed hot flashes and tired. My hand feels numb most of the time with electric shock feeling going through it or like a vibrating.  Some spasms still. Getting random aches in right leg and Very mild pin feeling in leg. Mild headache, in areas of head I?ve never felt before.  Tired. Started light spotting not supposed to start next menstrual cycle for 3 more days. - 23rd, hot flashes. Very mild Pain/mild numbness , arm spasming. Right leg has some numbness, pain. Mild headache, tired. Saw allergist said it seems like i am having anxiety induced symptoms. I can decide to take moderna again or a non mRNA vaccine. He says I am not having an allergic reaction and that my symptoms will stop once I decide. - 24th numb, hot flashes, sharp pains in arm woke me up twice while sleeping - 25th numb, left hand grip is getting weaker, saw chiropractor to see if adjustment would help. Gave some relief to sharp/needle pains temporarily. Arm is still numb. Arm becomes very tiered if I try to do anything to long
Narrative: COVID infection following COVID vaccine series 02/20, Pfizer, dose #1 03/15, Pfizer, dose #2 08/31 pt cc: rhinorrhea, sore throat, exposure: co-worker 08/31 COVID swab, result: detected
This non-serious initial spontaneous case, was received on 27-Sep-2017 from other health professional, concerning a patient of unspecified gender. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was administered with FLUAD (TIV) (dose, batch number, expiry date, route of administration, anatomical location: not reported), explicitly coded as inappropriate age at vaccine administration. The outcome of the events was not reported. The reporter assessed the events as non-serious.
my arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (my arm was sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE PAIN (my arm was sore). At the time of the report, VACCINATION SITE PAIN (my arm was sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient age was given as 13 may Concomitant medications were not provided Treatment medications were not provided   This case was linked to MOD-2021-291114, MOD-2021-291120 (Patient Link).
Pt received Moderna Vaccine at 0915. Pt complaint of "feeling like there is a lump in my throat" at 0930. VSS and taken at 0931 (BP 125/59 sitting RA, 97% RA, 72HR, 19RR AA O x 4). Examined airway and airway appeared to be intact. No difficulty in breathing. Pt speaking in complete and clear sentences. Pt drinking water and able to maintain secretions. Pt in NAD. States he is ready to go and did not want to stay full 30 minutes for observation even though he was advised to. At 0940 - pt states he "feels fine" and left in private vehicle at that time. No further treatment was needed or requested. Pt ambulatory out of vaccination area with even and steady gait, no assistance needed.
Pfizer-BioNTech Covid-19 Vaccine EUA.   On the evening of 2/16/21 I started itching on my hips. I noticed the following morning I had welts on my hips and it continued to spread  that day and for the next 3 days to my trunk, arms, face, chest, thighs and my upper lip swelled the evening of 2/19/21. I started taking Benadryl on 2/17/21 and discontinued it 2/19/21.  I started a Medrol Dose Pak on 2/18/21. The steroids started clearing up the welts on 2/19/21 and they were totally gone on 2/21/21.
Syncopal episode occurred 4 minutes after receiving first dose of Pfizer vaccine. Patient was seated in observation area and fell out of chair, sustaining minor head laceration. Medical team responded immediately and activated emergency medical response. Patient's vital signs were taken immediately after incident was identified (BP 86/52, HR 83), and again after 2 minutes (BP 92/70, HR 88).  Gauze was applied to head laceration. Patient regained consciousness and responded appropriately to medical team. EMS arrived 5 minutes after initial incident and took over patient care.
ringing in the left ear, whirling in the left ear & loss of hearing in the left ear
Patient reported fever max 99.8, HA, and muscle pain after receiving her second dose of Covid 19 vaccine.  She received the BioNTech Pzfizer Vaccine
3 days after vaccine started coughing up blood clots. Started off as a couple small clots then within a half hour later I coughed up the size of a quarter Went to ER and then was admitted.; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9269), intramuscular at the right arm on 05Feb2021 13:30 at single dose for COVID-19 immunization. The patient's medical history included rheumatoid arthritis (RA), transient ischaemic attack (TIA), atrial fibrillation (AFib), thyroid nodules, and back surgery. The patient's concomitant medications included methotrexate, atorvastatin, rivaroxaban (XARELTO), ergocalciferol (VIT D), and zinc. The patient was not pregnant at the time of vaccination. The patient previously took sulfur and acetylsalicylic acid;oxycodone hydrochloride (PERCODAN). The patient previously received the first dose of BNT162B2 (lot number: EL8982) on 15Jan2021, 01:30 PM at left arm for COVID-19 immunization. On 08Feb2021 23:45, 3 days after vaccine started, patient experienced coughing up blood clots. It started off as a couple small clots then within a half hour later, she coughed up the size of a quarter. She went to the emergency room (ER) and then was admitted for 3 days. The patient underwent lab tests and procedures which included nasal swab: negative on 09Feb2021. The patient had Cat Scans and broncoscopy as treatment for the event. Facility were the most recent COVID-19 vaccine was administered was reported as other. The outcome of the event was recovered on Feb2021.
Mild seizure; could not see; fainting; low blood pressure; Felt cold; This is a spontaneous report from a contactable consumer. A non-pregnant 13-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 15Jun2021 at 10:00 AM, at patient age of 13-year-old, as single dose (Lot number EwO191) for COVID-19 immunization. The patient had no COVID prior vaccination. The patient's medical history was none. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any medications within 2 weeks of vaccination. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 25May2021 at 15:00 PM, at patient age of 13-year-old, as single dose (Lot number Ew175) for COVID-19 immunisation. The patient experienced the adverse events from 15Jun2021 at 22:15 PM. The patient experienced mild seizure, could not see and low blood pressure, fainting. The patient felt cold and could not see is what she said before sitting in the chair at the pharmacy. The events resulted in doctor or other healthcare professional office/clinic visit. The patient was treated with laying down with propped up legs and water. The outcome of the events was resolved.  COVID was not tested post vaccination.
Patient s/p first dose Pfizer Covid vaccine, within 30 secs of receiving vaccine Sierra fainted, LOC x10secs, whole body limp, face and upper extremity color change pale/dusky, followed by generalized body shaking x10secs, followed by 10sec blank staring and no responding to her name or any questions. Placed in gurney and taken to Emergency Department.
4 month old patient was given 1 dose of Kinrix instead of Pediarix
negative titers and no immunity to measles, mumps, or rubella; negative titers and no immunity to measles, mumps, or rubella; negative titers and no immunity to measles, mumps, or rubella; Information has been received from a healthcare worker, referring to an unknown age female patient who was also the breastfeeding mother of a newborn baby. Information of and concomitant therapy was not provided.       On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, strength, route, lot# and expiration date were unknown) for prophylaxis (reported as unknown if patient ever received measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) vaccine).  On an unknown date, the patient had negative titers and no immunity to measles, mumps, or rubella. The outcome of the events was unknown. The relationship between the events and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not provided.
Patient complains of getting swollen lymph nodes on chest by the same side of the vaccinated arm 2 days after receiving dose. The arm itself is fine and not sore but the main concern is the swollen lymph node.
legs hurt; very weak; Rash appeared at point of Vaccination; Mussels around elbow are began to hurt; exhausted all the time; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (legs hurt), ASTHENIA (very weak), VACCINATION SITE RASH (Rash appeared at point of Vaccination), MYALGIA (Mussels around elbow are began to hurt) and FATIGUE (exhausted all the time) 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 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. 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 PAIN IN EXTREMITY (legs hurt), ASTHENIA (very weak), VACCINATION SITE RASH (Rash appeared at point of Vaccination), MYALGIA (Mussels around elbow are began to hurt) and FATIGUE (exhausted all the time). At the time of the report, PAIN IN EXTREMITY (legs hurt), ASTHENIA (very weak), MYALGIA (Mussels around elbow are began to hurt) and FATIGUE (exhausted all the time) had not resolved and VACCINATION SITE RASH (Rash appeared at point of Vaccination) outcome was unknown.            No relevant concomitant medications were provided.  No treatment information was provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Additional information received included additional events (weakness, leg pain and fatigue).
This spontaneous report as received from a nurse refers to a 22 year old patient. Nurse reported that patient of 22 years age was administered PROQUAD (inappropriate age) on 12-OCT-2013, subcutaneously. No adverse effects were reported. This case is linked to 1312USA005814 and 1312USA006027 due to same reporter link. Additional information has been requested.
Patient fainted immediately after injection of Gardasil vaccine. Patient was revived after about 10 seconds and was able to sit up. We had her rest in the office for 5 minutes. She was then able to walk out of the office on her own and is doing fine at home.
a patient under 65 years of age received HIGH DOSE QUADRIVALENT was given not Fluzone QIV vaccine with no reported AE; a patient under 65 years of age received HIGH DOSE QUADRIVALENT was given not Fluzone QIV vaccine with no reported AE; Initial information received on 28-Oct-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 61 years old female patient who was under the age of 65 were administered influenza quadrival A-B high dose HV vaccine [fluzone high-dose quadrivalent] instead of the fluzone QIV with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 27-Oct-2022, the patient received a once total dose of suspect influenza quadrival A-B high dose HV vaccine (lot UJ875AD , expiry date: 30-Jun-2023) at an unknown dose via  an unknown route  route in the left arm for immunisation.  On 27-Oct-2022, the patient who was under the age of 65 were administered fluzone hd qiv instead of the fluzone qiv with no adverse event (wrong product administered, product administered to patient of inappropriate age, latency: same day).  Action taken: Not applicable.  Outcome: Unknown for both the events.   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 the guidelines. 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 5/15/98 & 5/26/98 & pt exp a rash on the trunk;