chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pityriasis rosacea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 28Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization; Bnt162b2 (Dose 2), for COVID-19 immunization. The following information was reported: PITYRIASIS ROSEA (non-serious), outcome "unknown", described as "pityriasis rosacea".  Additional information: After receiving booster shot on 28Dec patient developed pityriasis rosacea and was seen by patient primary care physician he feels like this is a reaction from the booster shot that patient received just inquiring if this was something that has been common with the third shot.  The lot number for bnt162b2 was not provided and will be requested during follow up.
This spontaneous report received from a healthcare worker refers to a unknown number of patients of unknown age and gender. Since 23-MAY-2014 the suspect vaccines were improperly stored and on unknown date (in approximately May 2014) the patients were vaccinated with M-M-R II Lot #, dosage, anatomical localization and route of administration were not reported. Vaccines has been administered up to 8 patients. No adverse effects reported. This is one of the several reports of the same source. Additional information has been requested.
Not feeling usual self; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and MALAISE (Not feeling usual self) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On 01-Nov-2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced MALAISE (Not feeling usual self). At the time of the report, COVID-19 (COVID-19) had resolved and MALAISE (Not feeling usual self) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.         Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  She had fever on 23-Mar-2021 which was resolved on 25-Apr-2021. She was not feeling her usual self for a few days. It was unknown if patient was enrolled in a COVID-19 vaccine trial.   This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.
Tingling and numbness along trigeminal nerve on right side of face and down right arm (vaccine given on right arm). lasted until 7pm, around 4 pm, frontal migraine behind eyes, pupils pulsating, nausea and dizziness. better with sleep, still having symptoms today.
Symptoms were swollen eyelids and headache in the forehead area. Used Advil and Benadryl for treatment. Day one swelling subsided by end of day, I only took Advil. Day 2 I woke up and my eyes were swollen again. Took a Benadryl and am now awaiting the outcome.
tested positive for Covid-19 on 04May2022; tested positive for Covid-19 on 04May2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07May2021 as dose 1, single (Lot number: ER8735), in right arm, on 28May2021 as dose 2, single (Lot number: EW0173), in right arm and on 13Dec2021 as dose 3 (booster), single (Lot number: FJ1611) at the age of 48 years, in right arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "history of Triple Negative Breast Cancer (diagnosed 11Dec2012)", start date: 11Dec2012 (unspecified if ongoing). No Covid prior vaccination. Patient tested for Covid post vaccination. Concomitant medication(s) included: FLU VACCINE VII taken for influenza, on 18Nov2021; FOLIC ACID; ESCITALOPRAM OXALATE; CALCIUM; VITAMIN E [TOCOPHEROL]; VITAMIN D [COLECALCIFEROL]; FISH OIL. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 04May2022, outcome "recovering" and all described as "tested positive for Covid-19 on 04May2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test positive: (04May2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.
This spontaneous report was received from a medical assistant and vaccine provider and refers to a non-pregnant 33-year-old female patient. The patient's concurrent conditions included vitamin D deficiency, weight loss and nerve pain. There were no drug reactions or allergies reported. On 15-JUN-2018, the patient was vaccinated with PNEUMOVAX 23 0.5 ml, once, intramuscularly in right deltoid (lot # N034512, expiration date: 13-SEP-2019) as prevention of pneumonia and diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (TDAP) in right deltoid (lot # U5829AB, dose, strength, route of administration and expiration date were not provided) for prophylaxis. It was reported that she was well at the time of vaccination. The patient's concomitant therapies included ergocalciferol and phentermine hydrochloride (+) topiramate. On 16-JUN-2018, the patient sought medical attention and was seen by physician. During the office visit she reported body aches. On 16-JUN-2018, the patient had a strep test performed with a positive result and was diagnosed with "strep throat". On 18-JUN-2018 (also reported before as ''15-JUN-2018''), the patient experienced fever. On 18-JUN-2018, the patient also experienced hives on upper right arm, the arm being stiff, tight feeling, lightheaded, slight headache and arm redness and swelling. The patient received an unspecified treatment for the adverse events. Prescription drug treatment was not required. The outcome of the events was reported as recovered on an unknown date in 2018. The relatedness between the adverse events and PNEUMOVAX 23 was not reported.
This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient. A 70-year-old female patient received BNT162b2 (BNT162B2), on 08Apr2022 as dose 4 (booster), single (Lot number: FP4554) at the age of 70 years intramuscular, in right arm for covid-19 immunization. The patient's relevant medical history included: "Is the patient a smoker/former smoker? No" (unspecified if ongoing). Concomitant medication(s) included: VALTREX. Vaccination history included: BNT162b2 (Dose 1, Site of injection: Left Deltoid, Route: IM, Batch/Lot number: EH9899), administration date: 29Dec2020, when the patient was 68-year-old, for Covid-19 immunization, reaction(s): "COVID-19"; BNT162b2 (Dose 2, Site of injection: Right Arm, Route: IM, Batch/Lot number: EL1283), administration date: 15Jan2021, when the patient was 68-year-old, for Covid-19 immunization, reaction(s): "COVID-19"; BNT162b2 (Dose 3, Site of injection: Right Arm, Route: IM, Batch/Lot number: FD0809), administration date: 05Sep2021, when the patient was 69-year-old, for Covid-19 immunization, reaction(s): "COVID-19". The following information was reported: FATIGUE (non-serious) with onset Apr2022, outcome "unknown"; MYALGIA (non-serious) with onset Apr2022, outcome "unknown", described as "Muscle aches/pains"; CHILLS (non-serious) with onset Apr2022, outcome "unknown", described as "Sever chills with rigors".
C/O dizziness and neck pain34 minutes after vaccination.  BP 165-83, HR 53, pO2 99%.  dizziness persisted and patient brought to ED
The patient developed pain in the arm. Two days post vaccine, the site swelled and became red and hot to the touch. The pain began bolting up the arm.
This spontaneous report as received from a pharmacy technician refers to a 22 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 10-MAY-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source.; Sender's Comments: US-009507513-1802USA001558:
c/o throat tightness, neck hot and tight about 8 minutes after injection. Gave Epipen at 17:10 and taken by wheelchair to our ER.  Employee states she was monitored and given 1 liter of IV fluids and benadryl.  States she was discharged home about 3 hours later.  Felt exhausted 12/22/20.  Today feeling better.  Planning to see primary MD 12/24/20 for follow up.
Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). On 09-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Medications were provided by the reporter  No Treatment Information were provided by the reporter
mom reported to hlth unit 21AUG98 states went to ER;reports p/vax c/o arm hurting gave APAP;c/o arm pain next day & last noc  pt came in mom room c/o itching & arm hurting;mom turned on light found whelps starting from DTAP site;local rxn;
a 21 years old female pregnant patient was administered a dose of Fluzone HD instead of the regular"flu vaccine/No AE; a 21 years old female pregnant patient was administered a dose of Fluzone HD and Adacel/No AE; a 21 years old female pregnant patient was administered a dose of Fluzone HD/No AE; a 21 years old female pregnant patient was administered a dose of Fluzone HD/No AE; Initial information received on 13-Dec-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 21 years old female patient who was exposed to vaccines INFLUENZA VACCINE, DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (batch number: 3YN2L, expiry date: 12-MAR-2021, dose, route and site of administration were unknown) on 12-DEC-2019 and INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (batch number: UJ306AA, site of administration left deltoid, expiry date, dose and route) on 12-DEC-2019 instead of INFLUENZA VACCINE (regular flu vaccine), while she was pregnant.  Data regarding this pregnancy were received prospectively. The patient's currently pregnancy status is 34 weeks and 5 days.  The date of last menstrual period was not reported. The estimated due date was not reported.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was case of vaccine exposure during pregnancy. A 21 years old female pregnant patient was administered a dose of Fluzone HD and Adacel.  It was an actual medication error due to Wrong vaccine administered and Inappropriate age at vaccine administration. A 21 years old female pregnant patient was administered a dose of Fluzone HD instead of the regular flu vaccine.  It was also a case of overdose.  No adverse event reported.  Pregnancy outcome was unknown at the time of report.  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.
Sore throat, cough, lethargy, rhinorrhea, chills, sore arm.
Fever on and off since 7/26/07 (immunization day). Rash last night, worse today 8/7/06 (measles like rash) stuffy nose. Medicine given at home Motrin.
Initial information received on 27-Sep-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to case 2018SA272102 (same reporter). This case involves a 54 years old female patient who experienced she was "dizzy", had shortness of breath, she couldn't walk from the dizziness and just did not feel good, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history included Cardiac disorder on an unknown date. The patient's past medical treatment(s), vaccination(s) and family history were not provided. No concomitants. On 24-Sep-2018, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number: UI998AE and expiry date: 30-Jun-2019) in the left deltoid (dose in series and route of administration were not reported). On an unknown date, the patient developed a non-serious she was "dizzy" following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On an unknown date, the patient developed a non-serious had shortness of breath following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On an unknown date, the patient developed a non-serious she couldn't walk from the dizziness following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On an unknown date, the patient developed a non-serious just did not feel good following the administration of INFLUENZA QUADRIVAL A-B VACCINE. No Lab data was reported. Final diagnosis was just did not feel good, she couldn't walk from the dizziness, had shortness of breath and she was "dizzy". It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for she was "dizzy", as Unknown for had shortness of breath, as Unknown for she couldn't walk from the dizziness and as Unknown for just did not feel good. List of documents held by the sender: none.
On 4/17/21 patient woke up with bilateral shoulder pain and stiffness, right greater than left, neck stiffness, and right wrist tenderness. These symptoms waxed and waned until he was diagnosed with polymyalgia rheumatica and initiated prednisone on 6/3/21. Symptoms dramatically improved with this treatment.
Vomiting from 5:00 am to 6:00 pm. Headache. Chills.
From initial information received on 6/7/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 21 year old female patient received a second dose of IMOVAX RABIES, lot number W1419, on 11/21/03 as part of a post-exposure series. The route and site of administration were not reported. The same day, the patient experienced severe nausea, vomiting and diarrhea. The patient's recovery status was not reported. The reporter of this case is the same as for case 200402074.
Initial unsolicited report received from a nurse via sales representative on 13 October 2015. This case involves a female patient (age unknown) who was vaccinated with a dose of FLU VACCINE (batch number, expiry date and site of administration, route and dose series were not reported) on 09 October 2015. Medical history and concomitant medications were not reported. On an unspecified date, few days following the vaccination, patient experienced chills and high fever over the weekend. Patient's laboratory investigations and corrective treatments were not reported. The outcome of the events was not reported. Follow-up information received from a nurse on 20 November 2015. This case involves a 45 years old patient who was vaccinated with 0.5 ml of Flu vaccine (batch number: UI441AC) intramuscularly in the right deltoid on an unknown date. The patient's illness at time of vaccination, pre-existing physician diagnosed allergies, birth defects and medical conditions and any other vaccinations within 4 weeks of vaccinations reported as no. On an unknown date, the patient was recovered from the events (Duration: 2 days). List of documents held by sender: none.
Patient reports onset of burning pain down back of left upper arm to elbow within 1-2 hours after vaccine administration. Patient states arm is tender to touch and burning pain is constant, limiting comfort when lying in bed, etc. No rash, redness, swelling visible upon observation.
Patient mom reported that patient had sore left arm with redness. She told her mom it was causing some shoulder pain...pain felt like it was going up to shoulder. The red spot was more noticeable at first...but was subsiding when I spoke with mom.
Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: Patient blacked out and fell to the floor, he was unresponsive for a couple of seconds then regained consciousness.  He felt better after 5-10 minutes.
The only times patient gotten the flu was the times of the flu shot; Initial information received regarding an unsolicited valid non-serious case received from a consumer (patient) via Social media and transmitted to Sanofi on 27-Oct-2020.  This case involves patient with unknown demographics the only times who gotten the flu was the times of the INFLUENZA VACCINE shot.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, patient reported that the only times patient got the flu (influenza) was at the times when patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) (lot number unknown) via unknown route in unknown administration site for prophylactic vaccination.  Final diagnosis was influenza.   No relevant laboratory tests were reported.  It was not reported if the patient received a corrective treatment.  Event outcome was reported as Unknown for influenza.  Lot number will not available for this case.
Administered only the liquid component; Administered only the liquid component; Menveo administered to a 64 y/o; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 64-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA652A, expiry date 31st July 2023) for prophylaxis.   On 30th September 2022, the patient received Menveo. On 30th September 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication, inappropriate dose of vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 30-SEP-2022 Reporter's Comments: The nurse called to ask information about the administration of only the liquid component of Menveo without the meningococcal A lyophilized conjugate vaccine component, to a 64 years old patient. The nurse asked for recommendation about revaccination. The reporter consent to follow up. Additional Supportive Information: The patient received only the liquid component of Menveo without the meningococcal A lyophilized conjugate vaccine component which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. 64 years old patient received Menveo, which led to inappropriate age at vaccine administration.
Fatigue, fever over 100 degrees, nausea, sweating, cramps/diarrhea, vomiting, chest pain,  This all lasted about 30 hours total.
Narrative:  Patient reported red, raised rash to upper deltoid around where the injection was given. Patient requested a renewal of her hydrocortisone 2.5% cream, used that to help treat the allergic reaction. No further action needed, adverse reaction abated.