chrisvoncsefalvay/vaers-outcomes huggingface dataset:
little soreness in arm; Initial information regarding an unsolicited valid non-serious case was received from Pfizer (non-licensed partner) (MFR Control No: 202101287785) in the form of courtesy via a consumer/non-healthcare professional and transmitted to Sanofi on 30-Sep-2021.  This case involves a 69-year-old female patient (165 cm and 94 kg) who experienced little soreness in arm (pain in extremity) while received INFLUENZA VACCINE, MODERNA COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.  The patient's past medical treatments, vaccinations and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  Concomitant medications included RIVAROXABAN (XARELTO).  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route in a right arm for prophylactic vaccination.  On 29-Jan-2021, the patient received a dose of suspect PFIZER BIONTECH COVID-19 VACCINE not produced by Sanofi Pasteur (lot number: EN3318 and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On 20-Feb-2021, the patient received a dose of suspect MODERNA COVID-19 VACCINE not produced by Sanofi Pasteur (lot number: EL9267 and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On 28-SEP-2021 the patient developed a non-serious little soreness in arm (pain in extremity) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE, 8 months following the administration of PFIZER BIONTECH COVID-19 VACCINE and 7 months 8 days following the administration of MODERNA COVID-19 VACCINE.  It was reported "Caller reporting that she received both doses of Pfizer BioNTech Covid19 vaccine and when she got booster it was Moderna vaccine. She wants to make sure it is ok and that she will be covered. Will the immunity be effective?"  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  Advil as a corrective treatment was received for the event.  At time of reporting, the outcome was unknown for the event little soreness in arm.  There will be no information available on the batch number for this case.
Flu vaccine administered at 10 a.m. when I was 34 weeks and 5 days pregnant. This was a twin pregnancy with lots of monitoring (ultrasounds, etc.) At approximately 3 p.m., my OB observed normal fetal heart activity in both babies. At 5:30 p.m. during a nonstress test, it was discovered that baby A had developed atrial flutter, with a heart rate of 422. Babies were surgically delivered the next morning due to this condition. Baby A was successfully cardioverted into a normal rhythm. Baby A was kept in NICU for three days to monitor cardiac status. 4/17/09-records received for DOS 10/13-10/17/08-admitted with 35 week twin pregnancy with fetal arrhythmia. Scheduled repeat cesarean delivery.
prior covid infection, as I had in 2021 long covid caused by the vaccines; prior covid infection, as I had in 2021 long covid caused by the vaccines; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), 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 included: "pre-cancer diagnosis" (unspecified if ongoing); "mitral valve prolapse" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "prior covid infection, as I had in 2021 long covid caused by the vaccines". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: prior covid infection, as I had in 2021 long covid caused by the vaccines.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Loss of sensation to the left side of her face, specifically her left jaw and front left side of her tongue; Soreness in her arm; This spontaneous case was reported by a nurse and describes the occurrence of HYPOAESTHESIA (Loss of sensation to the left side of her face, specifically her left jaw and front left side of her tongue) and VACCINATION SITE PAIN (Soreness in her arm) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced HYPOAESTHESIA (Loss of sensation to the left side of her face, specifically her left jaw and front left side of her tongue) and VACCINATION SITE PAIN (Soreness in her arm). On 18-Jan-2021, HYPOAESTHESIA (Loss of sensation to the left side of her face, specifically her left jaw and front left side of her tongue) had resolved. At the time of the report, VACCINATION SITE PAIN (Soreness in her arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. Treatment included Ibuprofen
Swelling in her upper lip; Swelling above the upper lip; Not immunocompromised, got her third dose; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Swelling in her upper lip), SWELLING (Swelling above the upper lip) and OFF LABEL USE (Not immunocompromised, got her third dose) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052E21A, 030M20A and 042L20A) for COVID-19 vaccination.     No medical history was provided.  Concomitant products included HYALURONIC ACID (RESTYLANE) for an unknown indication.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Aug-2021, the patient experienced OFF LABEL USE (Not immunocompromised, got her third dose). On 27-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LIP SWELLING (Swelling in her upper lip) and SWELLING (Swelling above the upper lip). On 25-Aug-2021, OFF LABEL USE (Not immunocompromised, got her third dose) had resolved. On 31-Aug-2021, LIP SWELLING (Swelling in her upper lip) and SWELLING (Swelling above the upper lip) had resolved.            Treatment information was not provided.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's medical history and current conditions were not provided. On 23-OCT-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) (dose, frequency and route were not reported) lot # reported as L0010144, expiration date 24-MAR-2017. No adverse effects have been reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a Medical Assistant refers to multiple patients of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored RECOMBIVAX HB (dose, route, lot number and indication were not reported). No adverse effects reported. No product quality complaint involved. This is one of several reports from the same reporter. Additional information has been requested.
Drug ineffective; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) 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), outcome "unknown"; COVID-19 (medically significant), outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient was vaccinated and got COVID for the 2nd time in two years. Patient also prescribed Paxlovid.  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-202300150494 same reporter/patient, different drug and event;
bone pain; warmth; neck pain; headaches; This spontaneous case was reported by a physician and describes the occurrence of BONE PAIN (bone pain), FEELING HOT (warmth), NECK PAIN (neck pain) and HEADACHE (headaches) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced BONE PAIN (bone pain), FEELING HOT (warmth), NECK PAIN (neck pain) and HEADACHE (headaches). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, BONE PAIN (bone pain), FEELING HOT (warmth), NECK PAIN (neck pain) and HEADACHE (headaches) outcome was unknown.        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 product use was reported
08/30/22 presents to EC ED for "consistent nausea and vomiting". PMHx of "hypertension, thymoma s/p resection (2014), diabetes mellitus"
Vaccine dose was administered from the vial punctured for > 12 hours; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine dose was administered from the vial punctured for > 12 hours) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21A and 022C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine dose was administered from the vial punctured for > 12 hours). On 09-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine dose was administered from the vial punctured for > 12 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication were not reported.  HCP stated that Moderna COVID-19 vaccine was given to 4 patients yesterday (9Jun2021) from the vial which was punctured for more than 12 hours  Treatment information were not reported.
Papular, erythematous rash over extremities, pruritic; required steroid rx;
pt recvd vax; fever fluctuating between 100-105 for approx 5 days p/ vax; CBC nl, Lungs clear, no oth cpmplications;
For 3 days I had severe muscle aches and pains, muscle twitching in my arms and legs that would come and go with no pattern, feeling hot then cold all the time, headaches, nausea, not hungry and very tired and slept a lot.
This is a spontaneous pregnancy case. This 35-year-old female subject as enrolled in a study. The subject received BOOSTRIX .5 ml on 30th December 2014. The subject received BOOSTRIX at week 36 of the pregnancy and during the third trimester of pregnancy. On 30th December 2014, an unknown time after receiving BOOSTRIX the subject developed vaccine exposure during pregnancy (Non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was ongoing. Additional details provided: The patient delivery due date was in three weeks.
Vaccines rec'd 11/1/10 - Pt developed prolonged atypical febrile seizure requiring intubation.
It was missed that patient was 17 at the time of vaccination. Once noticed the patient was called an made aware if the situation. He stated he was not concerned as he was turning 18 in about 30 days. He was also made aware of the V-safe app to help monitor any side effects.
Red rash approximately an inch wide and 2 inches long; spread to about 3 inches wide and about 5 inches long; tender to the touch; Rash; it is itchy; Sleepy; Right arm at injection site itched; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL9269), via an unspecified route of administration in right arm, on 25Feb2021 at 01:30 PM (13:30) (at the age of 77 years), as dose 2, single, for COVID-19 immunization. The patient's medical history included being anemic due to chronic kidney disease (CKD), cancer, depression, and allergies to sulfa. The patient's concomitant medications included bupropion, valproate semisodium (DIVALPROEX), levothyroxine, and other unspecified medications. The patient previously took oxycodone and experienced allergies; first dose of BNT162B2 (Lot Number: EN5318) on 01Feb2021 at 12:30 PM (at the age of 77 years) for COVID-19 immunization (left arm); and the first dose of influenza vaccine inactivated SAG 3V (FLUAD; Lot Number: PFS 2020-21Bu) on 12Jan2021 (at the age of 76 years) for immunization. The patient was not diagnosed with COVID-19 prior vaccination. The patient did not look at site later that day. On 25Feb2021 (during the first night; also reported as Wednesday), it (right arm at injection site) itched. Then next morning (26Feb2021), the patient checked it and saw a red rash approximately an inch wide and 2 inches long. The day of reporting (28Feb2021; Sunday), the rash has spread to about 3 inches wide and about 5 inches long. It is tender to the touch and now it is itchy. It is still red. The patient also was sleepy on 25Feb2021 and needed to take a 1.5-hour nap. No treatment was administered for the events. The patient has not been tested for COVID-19 post vaccination. The patient had not recovered from the events.  Follow-up attempts are completed. No further information is expected.
Day 1 after vaccine: severe headaches, neck and back pain (constant all day) Day 2 after vaccine: severe chest pains, shortness of breath, neck stiffness (constant, all day)
Confirmed that no symptomatic adverse events were reported; Inbound call from medical assistant calling to report temperature excursion for GARDASIL-9.  Caller states that product was administered to patient following the temperature excursion.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 02-MAR-2023, the patient was vaccinated with an improperly storage human papillomavirus (HPV) rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, lot #W004648, expiration date: 06-OCT-2024, administered for prophylaxis (strength, and route of administration were not provided). Temperature excursion occurred at 34.4 Fahrenheit (F) for 15 hours. No previous temperature excursion was reported. No additional adverse events were reported. ; Sender's Comments:  US-009507513-2306USA010783:
High heart rate for at least 8 hours. 135 bpm normal 85. BP over ten points higher top and bottom. Major headache muscle pains for 3 days. Tiredness continues.
This spontaneous case was reported by a consumer and describes the occurrence of WHITE BLOOD CELL COUNT DECREASED (LOW WBC COUNT/White blood cell count low) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease and Ankylosing spondylitis. Concurrent medical conditions included Ankylosing spondylitis and Crohn's disease. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Jul-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Sep-2021, the patient experienced WHITE BLOOD CELL COUNT DECREASED (LOW WBC COUNT/White blood cell count low). At the time of the report, WHITE BLOOD CELL COUNT DECREASED (LOW WBC COUNT/White blood cell count low) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Sep-2021, White blood cell count: 3.1 No unit. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No concomitant medication were reported. The reporters causality for the event(s) of LOW WBC COUNT with HUMIRA(ADALIMUMAB) was a reasonable possibility. No treatment medication were reported. 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.
Day 9 after injection, redness/rash at injection site. Itching and slight swelling still continuing at day 12 after first dose
82 days after my vaccination - I experienced post menopausal bleeding - and it was profuse.  The bleeding lasted almost 4 days.  I consulted with my gynecologist.  He scheduled for for a transvaginal ultrasound and pelvic examination.
Unknown Pneumonia vaccine made the arm very sore within 15 minutes. Within 45 minutes the top half of the upper arm was red, swollen, painful and itching.  Took Benadryl per Nurse?s recommendation.  Arm remained red, swollen and uncomfortable all day. Day 2 the redness and swelling encompassed the whole upper arm.  Day 3 the redness and swelling moved to upper half of forearm. Day 4 the redness and swelling moved to lower half of forearm and hand.  Day 5 the redness and swelling began to dissipate. Took Benadryl throughout.
FEVER; MUSCLE ACHE; FATIGUE; ELEVATED BLOOD PRESSURE; ELEVATED HEART RATE; IRREGULAR HEART BEAT; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included auto-immune disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and batch number: 1805022 expiry: 25-MAY-2021) .5 ml, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced fever. On 09-MAR-2021, the subject experienced muscle ache. On 09-MAR-2021, the subject experienced fatigue. On 09-MAR-2021, the subject experienced elevated blood pressure. On 09-MAR-2021, the subject experienced elevated heart rate. On 09-MAR-2021, the subject experienced irregular heart beat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, muscle ache, fatigue, elevated blood pressure, elevated heart rate, and irregular heart beat on 11-MAR-2021. This report was non-serious.
Random eye twitches in the right eye; This is a spontaneous report from a non-contactable consumer, the patient. A 28-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the right arm on 11Mar2021 at 11:45 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included lyme disease and allergic to mushrooms. 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 vaccination. Concomitant medications included unspecified birth control (MANUFACTURER UNKNOWN) and loratadine/pseudoephedrine sulfate (CLARITIN-D) both for an unknown indication from an unknown date and unknown if ongoing. On 11Mar2021 at 12:15, the patient experienced random eye twitches in the right eye. The event 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 event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event random eye twitches in the right eye was not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
Swelling and redness with raised white edge. Pt. was comfortable, no fever, emesis, pain, decreased ROM in limb, eating, playing and sleeping fine. Area was marked with pen to identify if it was getting larger. Spoke with mother 3 hrs after seeing child in clinic and she was taking child to hospital. E/R doc stated locallized reaction, but gave Bactrim anti-biotics and sent home. Spoke with pt. mother the next morning @ 8:40 am. Redness is lessened, but is still outisde the borders that were marked with pen. Not as hot and the raised white edge is gone completely. Mother has chosen to continue with antibiotics as suggested by E/R MD.
Patient reports shortness of breath and chest pain 7 hours after vaccine. Patient stating he has had ongoing shortness of breath with any exertion. Chest tightness in left side with breath in. Stating breathing feels "heavier." Ongoing headaches. Symptoms starting 7 hours after vaccine. Headache intermittent. Reporting breathing intermittently feels heavier.
Sore arm at injection site arm can barely move or lift it; Sore arm at injection site arm can barely move or lift it; This is a spontaneous report from a contactable other healthcare professional, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8839) via an unspecified route of administration in the right arm on 03Nov2021 at 14:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included sickle cell trait, pre-diabetic, gallstones/gallbladder disease, eczema and known allergy to grass. 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 vaccination. The patient did not receive any concomitant medication. On 03Nov2021 at 16:00, the patient experienced sore arm at injection site and could barely move or lift it. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event sore arm at injection site can barely move or lift it was unknown at the time of this report.