chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse event; Patient administered pediatric monovalent vaccine instead of bivalent booster; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient administered pediatric monovalent vaccine instead of bivalent booster) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Dec-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 21-Dec-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient administered pediatric monovalent vaccine instead of bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient administered pediatric monovalent vaccine instead of bivalent booster) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient administered pediatric monovalent vaccine instead of bivalent booster).    This case contains information for the 12th of 16 adult patients described by the reporter. No concomitant product reported by reporter. No treatment medication reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-692175 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 23-Dec-2022: Upon internal review on 20-Jan-2023, significant correction was performed to update the Worldwide unique case identification number; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-692175:master case
flu like symptoms; sore left arm; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd July 2019, the patient received Shingrix (intramuscular). On 24th July 2019, 1 days after receiving Shingrix, the patient experienced influenza-like symptoms and injection site pain. On an unknown date, the outcome of the influenza-like symptoms and injection site pain were unknown.   It was unknown if the reporter considered the influenza-like symptoms and injection site pain to be related to Shingrix.  Additional details were provided as follows: The batch number was not reported. The caller reported that the adverse events on behalf of his wife.  The patient was experiencing flu like symptoms and her left arm was sore.  Did not consent to follow up. The caller declined to provide the patient treating physician's information and her date of birth. This case linked with US2019134707, reported by same reporter.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), 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), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
After the first vaccine I had arm, shoulder and neck pain on my right side along with a lasting headache for a week or so; After the first vaccine I had arm, shoulder and neck pain on my right side along with a lasting headache for a week or so; After the first vaccine I had arm, shoulder and neck pain on my right side along with a lasting headache for a week or so; After the first vaccine I had arm, shoulder and neck pain on my right side along with a lasting headache for a week or so; This is a spontaneous report from a contactable other healthcare professional (HCP). A 40-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration in the right arm, on 06Jan2021 at a single dose, for Covid-19 immunization. Patient had no relevant medical history and no known allergies. Concomitant medication included escitalopram oxalate (LEXAPRO). The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. Facility type where vaccine was administered was reported as other . On an unspecified date in Jan2021, after the first vaccine the patient had arm, shoulder and neck pain on my right side along with a lasting headache for a week or so. The patient did not receive treatment for the events. Outcome of the events was recovering. The patient has not been tested for COVID-19 since vaccination.  Information about batch/lot number has been requested.
9/22/10 tingling sensation on left arm; left leg went numb twice; right eye lost control for less than a minute and felt lightheaded. Pt sent/referred to hospital per MD.
Sore arm from shoulder to wrist, headache, neck pain, severe nausea, chills, diarrhea, congestion--no fever; took advil, pseudophed, used a heating pad--resolved mostly by 3/16/21
2/20/21 Swelling of right leg 2/24/21 Seen at  nurses' clinic, referred to doctor, sent for D-Dimer Test, sent for Ultrasound of right leg, referred to to  Urgent Care.
Fever 102F checked at 6:30am. Woke up in sweats. Chills and aches all over the body, especially the back and joints. Heart palpitation, Headache, Nausea, Diarrhea, Dry Mouth, Weak, Light headed. Loss of balance. I did not reach out to my doctor yet. I am hoping all these symptoms will subside by this evening or tomorrow.
Death on 2/18/21. Pulmonary embolism found on autopsy.
NO ADVERSE EVENT THE PATIENT WAS GIVEN A VACCINE THAT HAD BEEN LEFT OUT FOR MORE THAN 24 HOURS. IT WAS TAKEN OUT FOR ROOM TEMPERATURE AT 10AM THE DAY BEFORE
patient received an expired vaccine; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received an expired vaccine) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033k21-2a, 029A21a and 012M20A) 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) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jun-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jun-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received an expired vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications reported. It was reported that the number of dose per vial was unknown. The date vial was initially stored in the refrigerator was unknown. Vial did not undergo any temperature excursions. Patient did not have any allergies. COVID test or diagnosis with patient was unknown. Patient did not have any medical history . Patient did not seek medical care like office visit, Urgent care, ER, hospitalized. Patient did not experience similar event in the past. Patient did not have any symptoms.  Other vaccines given within 1 month prior to Moderna COVID-19 vaccine like type, brand, lot, route, dose Zoster vaccine 3Jun2022 with lot number ms5hc.
Chills; body aches; nausea; vomiting; fever between 100 and 102 with Tylenol and Motrin that lasted 36 hrs; This is spontaneous report from a contactable nurse. A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular on the left arm first dose on 16Dec2020 06:00 (lot number: EK57303121) and second dose on 07Jan2021 16:45 (lot number: EL3246) at a single dose for COVID-19 immunization. The patient had no medical history. There were no concomitant medications. On 08Jan2021 05:00 AM, the patient experienced chills, body aches, nausea, vomiting, fever between 100 and 102 with Tylenol and Motrin that lasted 36 hrs. No treatment was received for the events chills, body aches, nausea, vomiting. The events resulted to a doctor or other healthcare professional office/clinic visit. Events were reported as non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No known allergies to medications, food, or other products. Outcome of the events was recovering.
administer expired vaccine to 450 patients, after the manufacture date of expiration.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to 450 patients, after the manufacture date of expiration.) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to 450 patients, after the manufacture date of expiration.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to 450 patients, after the manufacture date of expiration.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  It was reported number of doses /vials given as 102 on 25Oct2021,26Oct2021, 27 Oct2021 ,29 Oct2021. It was unknown when the vial was stored in refrigerator. The vial did not undergo any temperature excursions.  Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received, reporter address and patient details was updated. On 08-Jun-2022: Upon internal review on 15-Jun-2022, significant correction was performed. On 08-Jun-2022 case became valid but missed to tick the significant check box. Hence correction was performed to tick the significant check box for report submission.
Began with rash (small red dots) in diaper area 06/19/09) on 06/20 and 06/21/09 had red checks, low grade temp. slow progression of rash up abd to neck and back to occipital; rash is now blotchy, flat, no itchiness; child taking food/fluids; bowels/bladder moving.
5NOV97 mom described onset 4NOV inj site hard & swollen area size of walnut & becoming larger when lifts arm;also painful;no redness & streaking, or drainage;6NOV97 seen by MD hypertrophied area & muscle tissue;muscle aches in chest & neck;
Patient was taking a nap, mom noticed that she woke up but was having a seizure. She did have a fever of 101.0.
Patient received injection, within 20 minutes started itch and with rash, gave 40 mg Benadryl 1M, 40 mg Solumedrol 1M - patient then wheezed - gave Epi Pen jr. - stabilized.  Transferred to hospital ER via ambulance.
This spontaneous report was received from a medical assistant refers to a 6 month old patient. Information regarding patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were not provided. Medical assistant reported that on 21-SEP-2016, the patient was vaccinated with a dose of PEDVAXHIB and PENTACEL at the same office visit. No adverse effects were reported. Additional information has been requested.
upon awakening 30SEP pt c/o of stomachache-mom noted rash on arms, legs, trunk, abdo; rt arm @ inject site quite swollen & reddened;
Flu like symptoms; sniffles; little warm temperature of 100 degrees Fahrenheit; injection site was warm to the touch; sore when pressed on; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (injection site was warm to the touch), INFLUENZA LIKE ILLNESS (Flu like symptoms), RHINORRHOEA (sniffles), VACCINATION SITE PAIN (sore when pressed on) and PYREXIA (little warm temperature of 100 degrees Fahrenheit) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A, 048B21A and 0314210) for COVID-19 prophylaxis.     Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced VACCINATION SITE WARMTH (injection site was warm to the touch) and VACCINATION SITE PAIN (sore when pressed on). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), RHINORRHOEA (sniffles) and PYREXIA (little warm temperature of 100 degrees Fahrenheit). At the time of the report, VACCINATION SITE WARMTH (injection site was warm to the touch), INFLUENZA LIKE ILLNESS (Flu like symptoms), RHINORRHOEA (sniffles), VACCINATION SITE PAIN (sore when pressed on) and PYREXIA (little warm temperature of 100 degrees Fahrenheit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 degrees Fahrenheit.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No medical history was reported. The expiry date of the 1st dose was reported as  26-Sep-2021, 2nd dose was reported as 09-Oct-2021. It was reported that after both the 1st and second dose, the injection site was warm to the touch and sore when pressed on. After the booster dose, the patient had flu like symptoms, sniffles and a little warm temperature of 100 degrees Fahrenheit. The patient also took second booster dose on 22-Dec-2022 (lot:057M21A,expiry: 13-Aug-2022). No treatment medication was reported.   This case was linked to MOD-2023-730985 (Patient Link).
Patient stated that he experienced itching, swelling of the gums and tongue, and difficulty breathing about an hour and half after receiving vaccine. He reports going to Hospital ER on the Road where he was given Epinephrine, Famotidine, Benadryl, methylprednisone, Albuterol, and Racepinephrine . He was transported to the main hospital for further treatment.
This case was reported by a consumer via call center representative and described the occurrence of unwell in a adult male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced unwell. On an unknown date, the outcome of the unwell was unknown. It was unknown if the reporter considered the unwell to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient was asking about what would happen if more than 6 months goes by between 1st and 2nd SHINGRIX injection. The reporter was attempted to be transferred to escalation nurse but none were available. Prior to transfer reporter stated in reference to his 1st shot of SHINGRIX that, he got ill from it. The GSK called him back to answer his question and to obtain further adverse event details but his voicemail box was full and we were unable to leave a message. No further details known.
Quickly developed awful, sour smelling body odor; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration on 12Apr2021 at 15:15 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic autoimmune urticaria since an unspecified date. Concomitant medications included cetirizine hydrochloride (ZYRTEC), hydroxyzine (MANUFACTURER UNKNOWN), pregabalin (MANUFACTURER UNKNOWN), famotidine (MANUFACTURER UNKNOWN) and vitamin d (MANUFACTURER UNKNOWN) all for an unknown indication started on unspecified dates and unknown if ongoing. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration on 22Mar2021 at 15:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Apr2021 at 15:45, the patient experienced nothing severe but quickly developed awful, sour-smelling body odor. The event did not resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of this adverse event. The clinical outcome of the event quickly developed awful, sour-smelling body odor was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Hives, started on child's legs then wend up all the way to face. The next day his face was swollen, joints were swollen, wrists and ankles. Itchy skin, hives were changing shape and location on his body. On Friday 11/18/2016 All his back was read.
Site: Pain at Injection Site-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Additional Details: Immediately after injection, pt reported severe pain at injection site, nausea, dizziness and felt like he was going to pass out.  Gave pt water and he felt like he was going to vomit.  Patient very weak and almost passed out while sitting in chair. Patient asked to lay on floor and was moved to floor. Pharmacist called 911 to report symptoms/ask for EMS to come check vitals.  While waiting for EMS patient improved and father did not allow EMS to check patient.  Patient left on own.
Tingliness on lips; Dry throat; Dizziness; Migraine; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW 0164) via an unspecified route of administration in the left arm on 13Apr2021 at 14:30 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to shellfish and lamb. The patient had known allergies to ibuprofen. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021 at 14:30, within 5 minutes of vaccination, the patient experienced tingliness on her lips, dry throat, and dizziness. Dry throat continued for the remainder of the day. On 13Apr2021, the patient's migraine came the night of the vaccination and she had it even after 48 hours. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tingliness on lips, dry throat, dizziness and migraine was recovering at the time of this report.   No follow-up attempts are possible. No further information is expected
Client c/o sore arm and sore neck. On 12-17-01, symptoms resolved and client felt sore neck was due to a "bug".
A few days after first dose. Injection site was warm and then settled into just general soreness (e.g. sore/strained muscle). Lasted until 2nd dose. Become slight worse and persists to the same degree with no diminishment in sensation of soreness as of 03/29/21. Slight limit in range of motion due to pain.
Patient started having headache, nausea, vomiting, diarrhea, fever (102-103) and blurry vision. Mom called Dr that  morning and he stated to continue to give Tylenol and ibuprofen  and to report reaction. Mom stated he started feeling better and fever broke about 1500 Friday evening, 4/23/21.
child was administered ActHIB using sterile water instead of the diluent; Initial information received on 26-Jul-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves Child patient (age and gender unknown) who received vaccine HIB (PRP/T) VACCINE [ACT-HIB].  The patients past medical history, concomitant medication and family history were not provided.   On 24-Jul-2019, the patient received a dose of suspect HIB (PRP/T) VACCINE lot number not reported via unknown route in unknown administration site.  It was an actual medication error due to wrong solution used in drug reconstitution.  It was reported that child was administered ActHIB using sterile water instead of the diluent.  It was unknown whether patient experienced any adverse reaction after the injection.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  List of documents held by sender: none.  Information on batch number was requested for this case
Awoke with excruciating pain from neck, shoulder blade and down left arm. After many MRI's, diagnosed with Parsonage-Turner syndrome. Still have muscle weakness, and numbness in left hand and wrist. Have some muscle atrophy in left hand.
26 HOURS AFTER RECEIVING THE VACCINE, MY VISION WITH THE LEFT EYE STARTED TO DETERIORATE. THE DOCTOR ON CALL SUSPECTED RETINA DETACHEMENT AND ARRANGED FOR A RETINA SPECIALIST VISIT NEXT MORNING. THE RETINA SPECIALIST DOCTOR CONFIRMED THE RETINA DETACHEMENT AND PERFORMED SURGERY TO REPAIR IT THE SAME EVENING.  EMERGENCY SURGERY WAS PERFORMED. I AM STILL RECOVERING (RECOVERY IS ESTIMATED TO TAKE 6 MONTHS), WITH DISTORTED IMAGING FROM LEFT EYE AND DOUBLE VISION.