chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had pain from the injection; All of a sudden, it has become very severe; This is a spontaneous report from a contactable consumer (parent). A 12-years-old female (daughter) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: Unknown) via an unspecified route of administration on 16Aug2021 as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On Aug2021 the patient experienced had pain from the injection all of a sudden, it has become very severe. Consumer stated that the 12 year old twins were given COVID Vaccine today, about five hours ago, about like four and a half hours ago. Well the girls had pain from the injection but it was not that severe, now all of a sudden, it has become very severe. was that normal or was that a cause of a concern. Consumer further stated, "If I need to take my daughter to the hospital, that what I need to know." In response to further probing for safety report reporter stated, "No, it was not the right time and need to find out if my girls were fine." The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101065367 Same reporter/vaccine/event, different patient
Fever, Chills, muscle aces, runny nose, sore throat, no smell or taste, headache, fatigue, cough, shortness of breath, chest pain, abdominal pain. Quarantine for the time recommended and isolate.
Nurse says that they received an email saying that the vaccines that they received were not within the allowable shipping window. Caller says that 6 of the vaccines have been administered to patients with no reported adverse event; stating shipment received were not with in the allowable shipping window vaccines were received cold and placed with no reported adverse event; Initial information received on 27-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 6 patient(s) and it was reported that nurse says that they received an email saying that the vaccines that they received were not within the allowable shipping window. caller says that 6 of the vaccines have been administered to patients and shipment received were not with in the allowable shipping window vaccines were received cold and placed with no reported adverse event after receiving influenza quadrival A-B vaccine [Fluzone QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date in Sep-2023, the patient(s) received a unknown dose of suspect influenza quadrival A-B vaccine (lot number: UT8134JA; expiry date: 30-Jun-2024) via unknown route in unknown administration site for prophylactic vaccination. The information on batch number was requested.  On an unknown date in Sep-2023, nurse reported that they received an email saying that the vaccines that they received were not within the allowable shipping window. caller says that 6 of the vaccines have been administered to patients with no reported adverse event (poor quality product administered) (latency: same day) and shipment received were not with in the allowable shipping window vaccines were received cold and placed with no reported adverse event (product storage error) (unknown latency).  It was reported that vaccine was administered on 26-Sep-2023 and 27-Sep-2023.  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 and Regulatory Authority 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.  Additional information was received on 31-Oct-2023 from other health professional. Case validity was upgraded to valid case (incorrectly assessed as non-valid). Lot number and expiry date of suspect product was added. A new event of product storage error was added. Clinical course updated and test amended accordingly.
Started 12/20/2021 (week after booster)-Sore throat;  itchy, burning eyes; cough; sinus congestion; high blood pressure(140?s/80?s), below normal temp, o2 stats 98, hr 75; fatigue 12/28/2021-still sore throat, laryngitis, below normal temp, bp is normal(120/76); o2-96; fatigue ED 12/23/2021- *Regen-Cov infusion-12/23/2021 600 mg of casirivimab with 600 mg of imdevimab
Vaccine given 07/20/2005.  Mother called with redness, swelling, fever on 07/21/2005.  Recommended basic measure to decrease fever and swelling, and if doesn't respond to go see physician.  Mother took to hospital after clinic treated with Antibiotics (Amoxicillin) for Cellulitis.
Pt. received ZOSTAVAX 12/18/09;  Saw Derm. on 1/7/09 for rash.  Returned to medical center 1/10/09 + Dx'd zoster rash R thigh.  Tx'd NEUROTIN tapered dose.
Pt admitted on 8/19/2021 with multiple medical problems. Started having flu-like myalgias, fever, and chills on August 12. Thru the week, continued to have fever, chills, and some shortness of breath. Cough with some sputum. Day of admission woke up with some nausea and vomiting.  Loose stools also noted. COVID-19 positive with O2 Sat at 89% Possibly transferred to him from granddaughter who lives with him. She has not been vaccinated, patient is.  Pt discharged on 8/20/2021 back to home.  Monoclonal antibody dose was given day of discharge and started dexamethasone.
wrong vaccine/monovalent received instead of bivalent; No adverse event; This spontaneous case was reported by a patient family member or friend and describes the occurrence of WRONG PRODUCT ADMINISTERED (wrong vaccine/monovalent received instead of bivalent) and NO ADVERSE EVENT (No adverse event) in an 11-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: COVID-19 VACCINE (booster), Pfizer vaccine (Dose 2) and Pfizer vaccine (Dose 1). Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE, Pfizer vaccine and Pfizer vaccine.   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 WRONG PRODUCT ADMINISTERED (wrong vaccine/monovalent received instead of bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (wrong vaccine/monovalent received instead of bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      No concomitant medication information provided. The reporter was trying to find out if her children were given the monovalent or bivalent. She thought patient was given the wrong vaccine at the pharmacy. The pharmacy told that they gave the children the monovalent, but they were scheduled for the bivalent vaccine. The reporter stated her child received two Pfizer doses and a booster. She stated patient did not experience any adverse reaction. No treatment information provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-660584, US-MODERNATX, INC.-MOD-2022-660597 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-660584:Patient 1 (same reporter) US-MODERNATX, INC.-MOD-2022-660597:Patient 3 (same reporter)
On 7/12/21 patient came to healthcare center with parent to obtain Covid Vaccination. Patient was given 1st dose.  Patient did not exhibit or complain of any adverse symptoms during observation period.    On 7/23/2012, back office identified that recipient's birth date is 12/12/2008. This makes the recipient only 12 yrs and 7 months old; ineligible for Moderna vaccination for which minimum age is 18 years.    Phone call placed to legal guardian (grandmother) on 07/23/2021 to inform. Guardian stated that she understood but that patient has experienced no adverse symptoms since receiving the Moderna vaccine and she would like patient to receive 2nd dose as scheduled.
Had a seizure lasting about 20 minutes the day after vaccine given. Seizure started with staring, then started trembling and clutching her trunk, then "slowly slid into being out of it." Mom gave Diastat during seizure. No fever. 3-4 cm red area --> injection site.
I am 4 weeks pregnant.  I estimate the delivery to be April 2022.  I experienced breakthrough bleeding today that was not implantation bleeding, and is not the correct time for a period.  This occurred about a day and a half after the Covid Vaccine 1st shot.
Mild allergic reaction (tingling in mouth, splotchy red chest, itchy eyes) approximately 5-10 minutes after receiving the vaccine; itchy eyes and puffiness in face on and off from time of vaccine to present (7 days later); vaccine and/or subsequent mild allergic reaction triggered Functional Neurological Disorder symptoms (involuntary muscle activations in legs, face and neck, dystonic posturing of feet)
1-14-15 Pt was given ROTARIX diluent and KINRIX mixed together orally. The KINRIX was mixed instead of the ROTARIX - we called GlaxoSmithKline and CDC - mom aware and pt has received the ROTARIX today 1-16-15 the nurse prepared and the MD administered.
Started with a rash and swelling behind both knees but more pronounced in the right knee for both the rash and swelling. Days 6-8 I ran  a fever of 101.5 which eventually broke.  The rash is now mostly if not completely gone 18 days after the shot.
Headache, all over body aches, injection arm very sore, 99.6 temp, 4 days later arm still sore and head hurts when I stand up or bend over.
Covid 19, Moderna vaccine was given to patient as a booster dose when eligibility was only for immunocompromised patients as additional dose.
This spontaneous report was received from a registered nurse referring to patient of unknown age and gender. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX lot number: N001528 (expiration date: 13-JAN-2019) for prophylaxis (strength, route, dose or units were not provided) reconstituted with a properly stored sterile diluent (STERILE DILUENT). There was digital data logger involved. The storage characteristics were the following: - Temperature: 6 F to 14 F (8.4 F) for 9 hours and 45 minutes - Previous temperature excursion: 6 F to 14 F (10.9 F) multiple excursions involved; cumulative total 29 hours. No adverse effects were reported.
Had cold symptoms. Sharp pain in left shoulder periodically after shot given. Had pain during 1st week after shot.
This spontaneous report as received from a pharmacist refers to a 60 year old male patient. The patient's medical history was not specified. On 30-JUN-2015, the patient was vaccinated with a dose of ZOSTAVAX, (lot #, dose and site of administration were not reported) subcutaneously. In approximately 2015 (reported as after receiving ZOSTAVAX), the patient's arm turned brown down to his elbow. The patient called pharmacist. The outcome of skin discolouration was reported as not recovered/not resolved. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Elevated BP: 182/89 (144/74 night before), pain in arm, feeling tired/weak, slight headache, shivering during sleep, slight fever, redness at injection sight 3-4 days following injection. Normal on day five (5).
This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient. A 73-year-old male patient received BNT162b2 (BNT162B2), on 11Aug2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 73 years, in left arm for COVID-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN taken for diabetes mellitus. Vaccination history included: BNT162b2 (Dose 1, Lot Number: Unknown , Anatomical Location: left arm), administration date: 25May2021, when the patient was 72-year-old, for COVID-19 Immunization; BNT162b2 (Dose 2, Lot Number: Unknown , Anatomical Location: left arm), administration date: 15Jun2021, when the patient was 72-year-old, for COVID-19 Immunization; BNT162b2 (Dose 3, Lot Number: Unknown , Anatomical Location: left arm), administration date: 17Dec2021, when the patient was 72-year-old, for COVID-19 Immunization. The following information was reported: INSOMNIA (non-serious) with onset 11Aug2022, outcome "unknown", described as "It was hard to sleep last night". Additional information: The patient had no prior vaccinations within 4 weeks prior to administration of suspect dose. The patient did not experience any adverse event following prior vaccinations. The event did not require a visit to an emergency room nor physician office. The event did not require relevant tests. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Fever chills, body aches cough .I felt really bad and could not move out of bed . All symptoms lasted 4 days My fever was 101.5
This spontaneous report as received from a medical assistant refers to a 15 day old patient. The patient pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 15-JUL-2016, the patient received first dose of ROTATEQ (lot # M004508 and expiration date 29-JUN-2017) 2 ml, oral (Inappropriate age at vaccine administration). No adverse effects were reported. The patient also received second dose of RECOMBIVAX HB on the same day (captured in MARRS#1608USA001909). Additional information has been requested.
classical sx Kawasakis Disease;fever began the day p/vax 11/10/9 @ 101;11/1//99 fever 104;11/12/99 rash;11/14/99 mucous membrane change & conjunctivitis-treated;
I felt very nauseous 3 hours after the injection; I woke up feeling like I was in a zone or fog this morning. I feel very odd/weird today; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Mar2021 16:45 (Batch/Lot number: unknown) at the age of 45 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VITAMIN C [ASCORBIC ACID]; VITAMIN D [COLECALCIFEROL]; ZINC. The following information was reported: NAUSEA (non-serious) with onset 08Mar2021 19:00, outcome "recovering", described as "I felt very nauseous 3 hours after the injection"; FEELING ABNORMAL (non-serious) with onset 08Mar2021 19:00, outcome "recovering", described as " I woke up feeling like I was in a zone or fog this morning. I feel very odd/weird today". Therapeutic measures were not taken as a result of nausea, feeling abnormal.  Additional Information: The vaccine was administered at a hospital. The patient has taken multivitamin within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient has no known allergies and prior to vaccination was not diagnosed with COVID-19. Since vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 41-year-old male patient received BNT162b2 (BNT162B2), on 20Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATORVASTATIN, start date: 16Jun2022; ASPIRIN 81, start date: 16Jun2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown result. 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.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events.
Mother called and reported that on PM of 03/25 patient started running fever, by 03/26 at approximately 0400 the fever had gotten up to 104.2. Mother was able to get fever to break with luke warm bath and tylenol. Mother states fever has been running between 99-101 since 03/25 (03/25-03/28). Child also had fatigue, poor appetite, and did not sleep well. Mother took child to clinic and was told that child looked good no problems, and to continue to treat fever with tylenol and ibuprofen.
Sister 1 week ago obvious vesiculopapular rash generalized increased fever. Vaccinated 1 year. Now 1 week later. No fever. Only 6-8 spots.
Patient presented to clinic to have 2nd dose of Moderna COVID-19 vaccine, however, at clinic site she received Pfizer COVID-19 vaccine instead of Moderna as 2nd dose. Patient made aware.
Increase in central neuropathy on entire left side of body. Central neuropathy is an effect of stroke suffered 5-23-2016.
left upper eyelid twitching uncontrollably and involuntarily; This spontaneous case was reported by a consumer and describes the occurrence of BLEPHAROSPASM (left upper eyelid twitching uncontrollably and involuntarily) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 029A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced BLEPHAROSPASM (left upper eyelid twitching uncontrollably and involuntarily). At the time of the report, BLEPHAROSPASM (left upper eyelid twitching uncontrollably and involuntarily) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No relevant concomitant medications were reported. Treatment details were not provided.
Within 15 minutes I began to feel pain in upper chest and throat along with Difficulty swallowing.  I took Benadryl but this continued for about 6 hours
Initial unsolicited misuse report received from a non-healthcare professional (medical assistant) on 01-Sep-2016. This case is linked to 2016SA162906 (Same vaccine, same lot number, same reporter). This case involves a 2 female patient (age unknown) who was vaccinated with 0.1 ml dose of Adacel (Batch number: U5467AC, expiration date 08-Oct-2018 and site of administration was not reported) instead of Tubersol (Batch number: C4652AA, expiration date 22-Jan-2017 and site of administration was not reported) for a TB skin test intradermal on an unspecified date. It was reported that this 2 patients were brought back on another day for a subsequent visit for administration of TB skin test with Tubersol; and those 2 patients did not have any reactions after the Tubersol administration. Patient's medical history and concomitant medications were not reported. On an unspecified date post vaccination the patient developed redness and itching at the injection site. It was a case of wrong drug administered. Lab tests and corrective treatment were not reported. Outcome of event was unknown. List of documents held by sender: none.
Left arm became very swollen and red and hot to touch. Mother took child to the emergency room of our local hospital due to the size of the affected area. Reports the whole upper arm was swollen/ lasted 5 days.
itchiness; rash couple of inches below injection site; redness; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (itchiness), RASH (rash couple of inches below injection site) and ERYTHEMA (redness) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PRURITUS (itchiness), RASH (rash couple of inches below injection site) and ERYTHEMA (redness). The patient was treated with HYDROCORTISONE (CORTISONE [HYDROCORTISONE]) for Adverse event, at a dose of cream. At the time of the report, PRURITUS (itchiness), RASH (rash couple of inches below injection site) and ERYTHEMA (redness) had resolved.            No concomitant medications were provided.   This case was linked to MOD-2021-038241 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2021: AE resolved
Information has been received from a pharmacist referring to multiple unspecified patients of unknown age and gender. Information about patients' concurrent conditions and medical history was not reported. The pharmacist reported that on unknown dates the patients "might" have received doses of improperly stored PROQUAD (Merck) (lot#, dose and route were unknown). Concomitant medications were not provided. No adverse effects were reported. This is one of three reports received from the same reporter (other linked case # 1511USA009326 and 1511USA009327). Additional information has been requested.
Varicella Information has been received from a physician and a school nurse concerning a 11 year old male who on 04-DEC-1995 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck).  It was also noted that the child was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) on 03-APR-1995 and 02-MAY-2001. A school nurse reported to the physician that between 24-MAR-2005 and 09MAY-2005, the child developed a "more severe case" of chickenpox, noted to be breakthrough with 50 to 250 lesions. Unspecified medical attention was sought. The outcome was recovered. A product quality complaint was not involved. No additional information is expected.