chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sever swelling at injection site; This is a spontaneous report from contactable nurse via Pfizer Sales Representative. This nurse reported similar events for 3 patients. This is 2nd of 3 reports.  A patient of unspecified age and gender received the first dose of meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date at single dose and meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA), via an unspecified route of administration on an unspecified date at unknown dose: both vaccines were administered on the same arm for immunisation. The patient medical history and concomitant medications were not reported.  The patient experienced sever swelling at injection site (non-serious) on an unspecified date after use of the product with outcome of unknown.  No follow-up attempts are possible. No further information is expected. Information about batch number cannot be obtained. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019352013 same reporter/ drug/ AE, different patient.;US-PFIZER INC-2019351994 same reporter/ drug/ AE, different patient.
TESTED POSITIVE FOR COVID; FEELING UNDER THE WEATHER; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis, and other pre-existing medical conditions included: Patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 01-OCT-2021 for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. Age at time of vaccination 62 years old. No concomitant medications were reported. On an unspecified date, the patient experienced tested positive for covid, and feeling under the weather. Laboratory data (dates unspecified) included: COVID-19 virus test Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of adalimumab was not changed. The patient had not recovered from tested positive for covid, and the outcome of feeling under the weather was not reported. This report was non-serious.
Dizziness; Dizziness / she fell down as a result; severe vertigo / room is spinning; can't focus her eyes; headache; Fever of 101 degrees F; Nausea; Sweating; This case was reported by a consumer via and described the occurrence of fever in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose on 15th August 2020 in left arm).   On 28th November 2020, the patient received the 2nd dose of Shingrix. On 29th November 2020, 1 days after receiving Shingrix, the patient experienced fever, nausea, sweating and headache. On 30th November 2020, the patient experienced dizziness, fall, vertigo and difficulty focusing eyes. On an unknown date, the outcome of the fever, nausea and sweating were recovered/resolved and the outcome of the dizziness, fall, vertigo and difficulty focusing eyes were not recovered/not resolved and the outcome of the headache was unknown.   It was unknown if the reporter considered the fever, nausea, sweating, dizziness, fall, headache, vertigo and difficulty focusing eyes to be related to Shingrix.  Additional details were provided as follows:   The patient received 2nd dose of shingrix and next day experienced fever of about 101 degree F, nausea and sweating. 2 days after receiving 2nd dose of Shingrix, patient experienced severe vertigo and she was unable to focus her eyes and fell down. The patient experienced spinning room which she had never experienced in her life. The patient saw neurologist and currently was in doctor's office to look at her inner eye. MRI was scheduled 1 week from the time of reporting. On 30th November 2020, patient experienced dizziness and fell down and were not resolved. The reporter consented to follow up.
No adverse effects reported; The patient received PROQUAD and VARIVAX on 6/24/2019; This spontaneous report was received from a registered nurse, regarding a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. Concomitant medications included sterile diluent.   On 24-JUN-2019, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # R030805, expiration date: 22-APR-2020, albumin status: rHA) and with varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot # R034394, expiration date: 27-NOV-2020) for prophylaxis. Dose, dose number, route of administration and anatomical location were not reported for both vaccines. No adverse effects were reported.
24JUN becam unresponsive, turned pale; seen in ER 4-5 hrs; kept on 02 then adm to hosp; 16SEP92 heart monitor discontinued when pt became 6 mos of age; no problems @ this time;
Rash around Covid vaccine injection. When I first noticed, my arm felt really itchy and then  I Noticed two lumps around the size of a nickel each.  Less than an hour later itchiness subsided and my arm started to hurt and feel soar like when I first got the Covid vaccine.
Information has been received from a nurse concerning a 13 month old patient who on 16-MAR-2012 was vaccinated with a dose of VARIVAX (Merck) (lot# 669795/1381AA). The nurse mentioned that on 09-MAY-2012 the patient had outbreaks of varicella. The patient had contacted the office. At the time of the report, the patient's status was unknown. This was one of the several reports from the same source. Follow up information has been received from the registered nurse concerning the male patient with infantile seborrheic dermatitis and no illness at the time of vaccination. The patient's medical history included bronchiolitis. The patient was vaccinated subcutaneously in the left leg with lot # (669795/1381AA) of VARIVAX (Merck) on 16-MAR-2012 at 6pm. The nurse reported that the patient went to the clinic on 08-MAY-2012 with a rash. The patient returned on 09-MAY-2012 for rash follow up, with a rash described as "mild generalized macular, papulae, vesicles and pustules" and diagnosed with varicella. No treatment information was reported and there was no testing done. At the time of the report the outcome of patient had outbreaks of varicella was unknown. The relatedness for varicella was not provided for VARIVAX (Merck). A lot check has been initiated. Additional information is not expected.
low grade fever; Disease aggravation/having a "flare with pain at 7 out of 10". normally pain is at "4 out of 10"; Upper respiratory infection; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program (054550).  A 47 year-old female patient received tofacitinib citrate (XELJANZ XR), first regimen oral from 2020 (Batch/Lot number: unknown) to Jan2022 at 11 mg daily and second regimen oral (ongoing) (Batch/Lot number: unknown) at 11 mg daily; bnt162b2 (BNT162B2) (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: Covid-19 vaccine (Dose 1, Manufacturer unknown), for covid-19 immunisation; Covid-19 vaccine (Dose 2, Manufacturer unknown), for covid-19 immunisation. The following information was reported: CONDITION AGGRAVATED (non-serious) with onset Jan2022, outcome "not recovered", described as "Disease aggravation/having a "flare with pain at 7 out of 10". normally pain is at "4 out of 10""; UPPER RESPIRATORY TRACT INFECTION (non-serious) with onset Jan2022, outcome "not recovered", described as "Upper respiratory infection"; PYREXIA (non-serious) with onset 28Jan2022, outcome "unknown", described as "low grade fever". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for tofacitinib citrate was dosage not changed. Therapeutic measures were taken as a result of upper respiratory tract infection.  Additional information included that the patient  reports holding xeljanz xr for 2 weeks "early Jan2022" to receive covid booster. She have resumed Xeljanz XR but currently having a "flare with pain at 7 out of 10". Normally pain is at "4 out of 10". She reported upper respiratory infection recently, "finished z-pak last week". Again she has low grade fever today. Dose delayed. Md/do not aware.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown age and gender. Medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with either the second or third dose of GARDASIL after a longer than recommended interval, (dose, frequency and route of administration not reported). No adverse effects reported. No product quality complaint (PQC) was involved. No further information provided. Additional information has been requested.
After receiving immunization approx. 5 min following  patient became pale and felt as though was going to pass out. Juice & soda was given. Ice packs applied to neck & chest area. Patient was observed for approx. 20 min. Vitals taken. Physician was called into room to access pt. Patient was allowed to stand once felt better without any further symptoms.
ACHES; HAD A FALL; HAD A BRIGHT RED BRUISE; FEVER; This spontaneous report received from a patient concerned a 24 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies and was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 02-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 02-JUN-2021, the subject experienced aches. On 02-JUN-2021, the subject experienced had a fall. On 02-JUN-2021, the subject experienced had a bright red bruise. On 02-JUN-2021, the subject experienced fever. Treatment medications (dates unspecified) included: amoxicillin/clavulanic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, aches, had a fall, and had a bright red bruise. This report was non-serious.
Patient presents for redness and swelling to her right leg. Area is warmth to the touch, hard and red.
Returned to MD on 28APR94; chief complaint: pain to lt thigh; induration, redness, & tenderness at site;
She got covid; She got covid; This is a spontaneous report received from a contactable consumer from medical information team.  A 26-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date Apr2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "She got covid". Then, the patient received the second dose in Nov2021.  The lot number for BNT162B2 was not provided and will be requested during follow up.
Patient experienced redness and swelling around both injection sites. Date of service and reactivity began both on 9/11/23.  She went to clinic down the street and was prescribed Bactrim for presumed cellulitis.
Day 1 - headaches Day 2 - headaches & extreme fatigue  Day 2 & 3 - nausea
The vaccines were possibly out of temperature due to the move, during hurricane. They were transported in the refrigerator provided by the Department of Health with their respective blocks of ice, not accompanied by a thermometer.
Developed headache and became extremelt tired.  Site of injection became red and well as a red spot below the injection site. The following day had severe body aches and joint pain, headache and felt feverish/flush.  The redness on my left arm expanded. By Sunday (Day 4) the redness was a large area together, hot to touch and had distinctive red ring outline. Contacted doctor on Monday and scheduked video appointment to evaluate for possible cellulitis and for further instruction on treatment. Appointment at 4:15pm.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  It was reported that, there was no power outages that would have impacted the Moderna vaccine. However, the healthcare professional reiterates that because her facility was unable to download the digital data logger, they needed to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment with the state at this time. It was also reported that, no adverse reactions were reported by the patient.  No treatment medication was provided.
Arm has been swollen; Arm red; Arm painful when touch; Arm hard where the shot was; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm has been swollen), ERYTHEMA (Arm red), PAIN IN EXTREMITY (Arm painful when touch) and FEELING HOT (Arm hard where the shot was) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030a21a) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and Cholesterol.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced PERIPHERAL SWELLING (Arm has been swollen), ERYTHEMA (Arm red), PAIN IN EXTREMITY (Arm painful when touch) and FEELING HOT (Arm hard where the shot was). At the time of the report, PERIPHERAL SWELLING (Arm has been swollen), ERYTHEMA (Arm red), PAIN IN EXTREMITY (Arm painful when touch) and FEELING HOT (Arm hard where the shot was) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included Blood pressure and Cholesterol meds. No treatment information provided
Fatigue - slept for 7 hours directly after. Chills. Fever of 102 not relieved with Tylenol. Body aches. Nausea.
Redness, warmth, mild swelling around injection site with mild tactile tenderness; around 3 x 5 cm.  Instructed to treat with ibuprofen otc, rest, ice prn, and elevation; recheck if worsens.
heart rate went really high / fast heart rate; This case was reported by a consumer via other and described the occurrence of heart rate increased in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of heart rate increased (received 1st dose on an unknown date. For the tolerance of 1st dose, refer linked case US2021AMR027252).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 6 hrs after receiving Shingrix, the patient experienced heart rate increased. The patient was treated with betamethasone + clioquinol + gentamicin + tolnaftate (Quadruple). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the heart rate increased was recovered/resolved.   It was unknown if the reporter considered the heart rate increased to be related to Shingrix.  Additional details were provided as follows: 6 hours after receiving Shingrix, the patient experienced fast heart rate. The reporter stated this lasted for quite a while and she already had medications in the house, and she had to Quadruple the amount that she would normally had taken. The reporter stated to this day she was still unsure what exactly in the Shingrix vaccine caused her reaction. The reporter stated she was not sure if she should receive the COVID vaccine or not. She also would like to know if there might be a connection or common ingredient in the Pfizer COVID vaccine.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR027252:same patient
Addisonian crisis by evening of shot.  Went into hospital the next day for treatment.
Extended menstrual period (more than 10days); Low fertility hormones; This is a spontaneous report from a non-contactable consumer, the patient. A 37-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration on an unknown date (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On an unknown date, the patient experienced extended menstrual period (more than 10 days) and low fertility hormones. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date, the patient underwent lab tests and procedures included fertility hormonal test and the result was found to be low fertility hormones. The clinical outcome of the events extended menstrual period (more than 10 days) and low fertility hormones was not resolved at the time of this report.    No follow-up attempts are possible. No further information is expected.
Fatgiue; Weakness; Headaches; Lightheadedness; Slight cough; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03Mar2021 at 01:15 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included mononucleosis and Epstein Barr in 1996. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included finasteride (PROPECIA), fexofenadine hydrochloride (ALLEGRA) and cyanocobalamin, pyridoxine hydrochloride, thiamine hydrochloride (VITRON); all from unknown date for unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021, the patient experienced fatigue and weakness, headaches, lightheadedness, slight cough. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had been tested for COVID-19. On 25Apr2021, the patient underwent Polymerase Chain Reaction (PCR) test for COVID- 19 via nasal swab and the result was negative. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events fatigue and weakness, headaches, lightheadedness, slight cough was not resolved at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Expired dose administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 42-year-old male patient who received HBV (Engerix B) (batch number 2793Z, expiry date 5th December 2022) for prophylaxis.   On 8th December 2022, the patient received the 3rd dose of Engerix B. On 8th December 2022, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 8-Dec-2022 Reporter's comment:  The nurse stated that when she looked at the expiration date she thought the year of expiration was 2023 and it was not until after the administration of the dose that she saw the year of expiration was 2022.  This was dose three in the patient's series. Permission granted for follow up from safety. The reporter consented to follow-up. Additional supportive information: The patient was inadvertently given an expired dose of Engerix-B, which led to expired vaccine used.
pt recvd vax & following the 3rd dose exp pain in the inguinal area; pt wanted to remain anoymous & would not provide name or address; Therefore, no further details are available
was down for a couple days with fever; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced fever. On an unknown date, the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the fever to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 01-SEP-2022 Reporter's Comment: This case was reported by the patient via  interactive digital media. The patient received a dose of Shingles vaccine and patient was down for a couple of days with fever but better than getting shingles. The patient would do it again for sure. Additional Supportive Information: This case had been linked with US2022AMR127532 reported by same reporter.  The follow-up would not possible as no contact details were available.
CERVARIX was given a male patient, while it should be given to the female patients, only.
Rash all over body, slowly going away, patient was in pharmacy on 10/19/20 and still had bumps on back of neck.