chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a serious observational study case, concerning a 31-year-old, adult pregnant female, subject of body weight: 128 lbs and height: 62 inches, body mass index (BMI): 23.4, enrolled in a prospective observational safety study. The subject's obstetrical history included a total 6 previous pregnancies with 4 previous full-term births (no birth defects reported) and 2 spontaneous abortions. The subject had no maternal or paternal history with major congenital malformations. The subject did not have a prior history of use of tobacco, alcohol or illicit drugs during pregnancy. The subject's current conditions included vaginitis and anemia (since unspecified dates). The subject's concomitant medications included Prenatal vitamins for pregnancy, METROGEL for vaginitis and ferrous sulphate for anemia. The subject's last menstrual period (LMP) date was 07-Apr-2018. The type of pregnancy was singleton. On 21-May-2018, the subject had an ultrasound which showed no major congenital malformations. On 01-Jun-2018, the subject had an ultrasound which showed no major congenital malformations. On 30-Jul-2018, the prenatal spinal muscular atrophy test, cystic fibrosis mutation analysis and Maternal Serum Alpha-Fetoprotein (serum markers) was performed which showed no major congenital malformations. On 19-Oct-2018, at gestational age of 28 weeks, the subject was administered Flu Vaccine Cell Subunit QIV NVD (batch number: 252664, dose, route of administration, expiry date and anatomical location: not reported) for an unknown indication. On an unspecified date in 2018, the subject was noted with pregnancy complications which included echogenic foci and pericardial effusion at gestational age of 32 weeks and chronic hypertension. The subject delivered a full-term female infant at gestational age of 37.6 weeks via vaginal method of delivery. The infant's birth weight was 2155 grams (low birth weight), body length was 45.7 cm and head circumference was 30.5 cm. The APGAR scores were 8 (one minute) and 9 (five minutes). The subject's estimated delivery date (EDD) was reported as 12-Jan-2019. This case linked to 201900314 (baby case). The outcome of the events was not reported. Reporter's Comments: A 31-year-old female pregnant subject experienced chronic hypertension, abnormal USG scan (echogenic cardiac foci and pericardial effusion) at 32 weeks of pregnancy, after receipt of Flu Vaccine Cell Subunit QIV NVD. Due to the lack of information important for the causality assessment, such as onset latency between the vaccination and reported event chronic hypertension, the company assessed the causality as unassessable. The event vaccine exposure during pregnancy assessed as not related considering the special case scenario. The company assessed the case as serious (medically significant).
No additional AE information provided.; temperature excursion/ Temperature 19.47F; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 01-DEC-2022, varicella virus vaccine live (Oka/Merck) (VARIVAX) was stored with temperature excursion. The temperature was 19.47 Fahrenheit (F) for 50 minutes. The vaccines did not experience previous temperature excursion before. On 13-DEC-2022, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) which experienced temperature excursion (0.5 ml, lot#: W018825, expiration date: 14-JUN-2024; strength, route of administration, and anatomical location were not reported) for prophylaxis (product storage error). No additional adverse event (AE) information was provided (no adverse event).
Painful, swollen, hot, rock hard injection site. Temp 102.5, extreme chills, body aches , nausea and headache. Hurt to open mouth the following day because jaws were so sore from clenching my teeth with the chills.  Skin hurt to touch, took a shower to try and warm up and the water hurt when it hit my skin.  Eyeballs hurt and felt hot and dry.
Second dose...got it around 5/5:30PM, arm felt sore 2 hrs after, about 12 hours after I started having flu like symptoms. 2 weeks later I started having major chest pain when leaning forward.
alopecia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program, reporting the same event under the same product for 6 patients. This is one of 6 reports.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Single, unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 2, Single, unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 3 (Booster), Single, unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 4 (Booster), Single, unknown manufacturer), for Covid-19 immunization. The following information was reported: ALOPECIA (non-serious), outcome "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-PV202300179111 same reporter/product/event, different patient;
Progressive difficulties walking and weakness. Symptoms started 12-9-11 with increasing back pain. Transferred care to another clinic and admitted to hospital. 5 day course of IVIG. Discharged on 12-21-11 with PT and OT referral.
Started to break out on 12/3/99 w/small blistered rash, that itches; was diagnosed on 12/3 by MD as chicken pox.
pt recvd vax on 2PM on 24MAY93 mom states pt ok when lt clinic & then about 5PM began crying & cried almost continuously; called MD & was told to give APAP & to apply warm compress instead of cold compression;
Severe flatulence [atypical for me] lasting about four hours; followed by intense, profuse diarrhea.  Diarrhea lasted another four hours or so.  Also had minor fever/chills, which are not a concern.  Still feel 'under-the-weather' twenty-four hours later [at time of this reporting].
Was shaking when getting out of the car seat and has been "out of it" all day. Temp of 99.6.  After getting home from the office visit.
This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2689) via an unspecified route of administration in the left arm on 05Nov2021 at 13:30 (at the age of 59-year-old), as a single dose for COVID-19 immunisation. Medical history included diabetes and high blood pressure. The patient had no known allergies. 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 vaccine. Concomitant medications included LISINOPRIL 20mg, MONTELUKAST 10mg, and JARDIANCE 25mg, all for an unknown indication on an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2589) via an unspecified route of administration in the left arm on an unknown date (reported at 13:30) and received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date; both as single dose for COVID-19 immunisation. On 06Nov2021 at 06:00, the patient experienced fever, violent chills, headaches, night sweats, neck joint pain, and nausea. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, violent chills, headaches, night sweats, neck joint pain, and nausea was resolving at the time of this report.
REC'D IMZ IN LEFT ARM SAT 9/9 WITHOUT ISSUE. PT CALLED SUN (9/10) MORNING STATING HER RIGHT HAND HURT. NO REDNESS, SWELLING OR VISIBLE RASH. NO ISSUES AT INJECTION SITE. SPOKE WITH HER LATER IN THE AFTERNOON - HAND FELT BETTER - NO LONGER HURT.
This spontaneous report as received from a physician via a representative refers to a 19 year old female patient with chlamydia (four weeks prior, treated with an unspecified antibiotic) and pre-existing genital warts (treated with Aloe Vera). On approximately 11-MAR-2013, about two weeks ago, the patient was vaccinated with the first dose of GARDASIL. It was reported that in approximately 2013 the patient had left upper quadrant pain with nausea and vomiting following vaccination with the first dose of GARDASIL. The patient sought unspecified medical attention by office visit. At the time of the report, the outcome of the event was unknown. Additional information has been requested.
PATIENT CAME TO OFFICE ON 10/31/02007, HAD RECEIVED VACCINES ON 10/29/07. LEFT THIGH SWOLLEN, RED, HOT AND PAINFUL TO TOUCH. (NURSE WAS GOING TO GIVE INJECTIONS IN ARMS, BUT PATIENT PREFERRED LEGS). MD NOTED AREA OF ERYTHEMA, WARMTH, AND TENDERNESS ON LEFT THIGH, ALSO STATES PT REACTED TO BANDAID. DXED WITH CELLULITIS AND PLACED ON SEPTRA X7 DAYS.
Initial information received on 15-Nov-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a 17 months old female patient who accidently received vaccine ADACEL instead of DAPTACEL (formulation: Suspension for injection for both vaccines). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MMR VACCINE for Immunisation; and ACTHIB for Immunisation. On 14-Nov-2018, the patient received a 0.5 ml single dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U6043BA (expiry date: 22-Aug-2020) via intramuscular route in the right thigh. It was a case of actual medication error due to Inappropriate age at vaccine administration and Wrong vaccine administered. It was reported that no adverse event occurred. 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 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.
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions or medical histories provided. On unknown dates (reported as on or after February 2016), the patients were vaccinated with improperly stored doses of VARIVAX lot # M027886 with expiration date on 03-JUN-2018 (dose and route of administration were not reported). The sterile diluent (MRK) used for reconstitution did not undergo a temperature excursion. There was no adverse effect reported. Administered doses of vaccines experienced unknown temperature excursion for unknown time. Data logger was involved. There was previous excursion reported. This is one of several reports received from the same reporter.
Rapid heartbeats; This is a spontaneous report from a contactable consumer (patient). An 84-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EL3247), via an unspecified route of administration on 21Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced rapid heartbeats on 22Jan2021 and did not received treatment. Consumer stated, "48 hours ago on 21Jan2021, I had the Covid-19 vaccine, first shot. I had a rapid heartbeat last night on 22Jan2021. And today this morning on 23Jan2021, I had a rapid heartbeat. It is more than 24 hours later I had rapid heartbeat and I still have it this morning on 23Jan2021". The patient underwent lab test which included Heart beat: increased on 22Jan2021. The outcome of the event was unknown.
devel lumps under skin under side of upper rt arm around elbow;the following day the lumps were on lower arm near wrist;area did not appear red, but seemed like a pliable, fluid filled area about 3x3 area;
This spontaneous report was received from a registered nurse concerning on multiple unspecified patients. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the multiple unspecified patients received improperly stored doses of VAQTA injection, (lot # M036459; expiration date: 18-JUN-2018), (route of administration, strength and dose were not reported) for prophylaxis. The temperature excursion with VAQTA was at 58 Fahrenheit degrees for 28 hours. The temperature excursion was detected by a data logger. There were no prior excursions. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA010295: US-009507513-1612USA010293:US-009507513-1612USA010294: US-009507513-1612USA003446: US-009507513-1612USA010292:
has not received her second shot; Developed sharp pains in front of her legs and in her quadriceps; Diarrhea; Joint pain; Fatigue; Headache; Chills; Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness), DIARRHOEA (Diarrhea), PAIN IN EXTREMITY (Developed sharp pains in front of her legs and in her quadriceps), PRODUCT DOSE OMISSION ISSUE (has not received her second shot) and ARTHRALGIA (Joint pain) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness). On 16-Jan-2021, the patient experienced DIARRHOEA (Diarrhea), ARTHRALGIA (Joint pain), FATIGUE (Fatigue), HEADACHE (Headache) and CHILLS (Chills). On 20-Jan-2021, the patient experienced PAIN IN EXTREMITY (Developed sharp pains in front of her legs and in her quadriceps). In February 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (has not received her second shot). On 20-Jan-2021, PAIN IN EXTREMITY (Arm soreness), ARTHRALGIA (Joint pain), FATIGUE (Fatigue), HEADACHE (Headache) and CHILLS (Chills) had resolved. In February 2021, PRODUCT DOSE OMISSION ISSUE (has not received her second shot) had resolved. At the time of the report, DIARRHOEA (Diarrhea) and PAIN IN EXTREMITY (Developed sharp pains in front of her legs and in her quadriceps) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing was delayed on an unknown date.       No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Patient was suspicious about the call so representative provided her Moderna Medical Information number to leave her details. On 22-Apr-2021: patient reported she delayed her second dose of the vaccine on advice from her HCP, because of the side effects she experienced with first dose. Her HCP advised her to wait for 4 to 6 months, she plans on getting the second dose. Action take with vaccine was updated.
Phone call this morning, 12/4/2020, Pt reports had flu vaccine  and two or three days later had discomfort in left shoulder. Reports discomfort continues till today with stiffness  or freezing up to area of injection site. Plans to see primary care provider.
Headache began approximately 5 hours after injection but resolved by following day, muscle soreness in left arm began almost immediately and was still present 2 days later,  fatigue began midway through the day after injection but resolved late in the day 2 days after, nausea present approximately 6 hours after injection but resolved before waking up the following day, rash appeared approximately 26 hours after injection and still present at this time.
Patient returned to Medical Dept saying he felt weak and his throat was closing up. He was seen by the PA and the MD.  Patient had grossly swollen posterior oropharynx and could barely speak. He could not swallow water.  He was given epi-pen X 2 and the ambulance arrived to take him to the ER where he was intubated.
Got shot on the 30th, on April 1st,  5th, 14th and 15th I have had mini seizures. No history of any either. They can't find out what has caused the seizures. But the vaccine is the only thing that has changed. All test have came back clear so far.
started feeling dizzy 730AM; diarrhea episodes 6AM & 1PM; nausea started 730PM; blotches on neck 730AM until 8AM; no resp problems; no swelling problems; slept a lot today;  sensation of water shooting up neck;
Erythema, swelling and tenderness 3" x 6" (R) deltoid symptoms started a few hours after vaccination. Treated with Azithromycin 200mg 1 tsp, 8ml po x 1d, 4ml x 4 days.
On the second day after the  3rd Booster vaccine I woke up with  a  large  warm, red blotch on the injection site. Today its about 3 inches in diameter. I had used an ice pack  for the pain in my arm the night prior.   I did have a similar reaction to the  first injection  but not until 10 days after the vaccine, and it was larger.  I was told by the pharmacy to use benadryl  or ice to help the first time.
Low grade ovarian cancer; Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of OVARIAN CANCER (Low grade ovarian cancer) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Ultrasound scan NOS (The results were reported as normal and clear.) on 04-Mar-2021. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 13-Mar-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 24-Dec-2020 and the estimated date of delivery was 30-Sep-2021. On 13-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On 26-Mar-2021, the patient experienced OVARIAN CANCER (Low grade ovarian cancer) (seriousness criterion medically significant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  eleventh week of the pregnancy.  On 13-Mar-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. At the time of the report, OVARIAN CANCER (Low grade ovarian cancer) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This is a case of product exposure during pregnancy in a patient who was diagnosed with Ovarian Cancer after receiving the first dose of mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. The patient will continue to be contacted for further monitoring of AEs during the pregnancy.; Sender's Comments: This is a case of product exposure during pregnancy in a patient who was diagnosed with Ovarian Cancer after receiving the first dose of mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. The patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Violent diarrhea the following day and contuing; This is a spontaneous report from a contactable consumer (patient herself). A 72-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration in right arm on 25Feb2021 (age at vaccination: 72-years) as dose 2, single for covid-19 immunisation. Historical vaccine included first dose of BNT162B2 (Lot number: EL9265) via unspecified route in right arm on 03Feb2021 1:00 PM (age at vaccination: 72-years) as dose 1, single for covid-19 immunisation. Patient medical history included high blood pressure from an unspecified date and unknown if ongoing. Patient experienced violent diarrhea the following day on 26Feb2021 and is continuing. The adverse event resulted in doctor or other healthcare professional office/clinic visit, Treatment was given as a result of the adverse events, and was still in process. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Device date was reported as 19May2021. The outcome of event was not recovered.   Follow-up attempts completed. No further information expected.
In the middle of September I started having pain in my left leg and was already in treatment for my prostrate cancer. I went out of the country and by the end of  September around 09/30/2021 I  develop pain in left leg that gradually got worse that was diagnose that clot behind Left knee. Th0ey did a CT scan of my chest, abdomen, and bone scan  on 12/2/2021 after my last Chemotherapy. They were not expected to see   multiple Pulmonary emboli in my lungs.  I was feeling a bit short of breath going upstairs and they needed to determine where they were coming from so they did a scan of legs and found on clot on my left knee. I was placed on Blood thinner Eliquis.  It took about 1.5-2 months for the pain to get better  but I have to continue the Eliquis until it's completely clear. They have not decided yet when to do another ultrasound.  D-dimer marker was highly elevated at 7.56MCG very high and it went down to .5mcg  December 22, 2021 and it February 23, 2021 0.6 at the beginning but it is very close to normal.  The Pulmonary Emboli in my lungs has also gotten better. I have no pain anymore. Clots can take time to slowly dissolve. Clinically how I feel I feel that it is obviously resolving.
Swollen lymph nodes in his left arm pit that worsened overnight; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph nodes in his left arm pit that worsened overnight) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes in his left arm pit that worsened overnight). At the time of the report, LYMPHADENOPATHY (Swollen lymph nodes in his left arm pit that worsened overnight) outcome was unknown.     No concomitant medications information was reported.  No treatment medications were provided.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) was not applicable.  It was reported that patient would be seeing his primary care physician on 17-Nov-2021   Most recent FOLLOW-UP information incorporated above includes: On 20-Nov-2021: Follow up received on contains no new information