chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fetal exposure during pregnancy; Low birth weight; Preterm birth; This is an observational study case, initially received from other health professional on 08-Oct-2019, concerning a female, neonate subject, whose mother was a 34-year-old female of body weight 294 lbs, height 62 inches and body mass index (BMI) 53.8 and father 35-year-old, enrolled in a prospective observational safety study.  The mother's medical history included obesity. Concomitant medication included Prenatal vitamins (minerals not specified (nos), vitamins nos) and Terazol (terconazol).  The mother's obstetrical history included three previous pregnancies. The subject's mother had no maternal or paternal history with major congenital malformations (MCMs). The mother did not use tobacco, alcohol or illicit drugs during pregnancy.   The mother's last menstrual period (LMP) was on 13-May-2018 and type of pregnancy was singleton. The estimated date of delivery (EDD) and corrected EDD (CEDD) of subject's mother was reported as 17-Feb-2019. The pregnancy was complicated with gestational hypertension, yeast and placental abruption.  On 05-Nov-2018, the mother underwent spinal muscular atrophy test and cystic fibrosis mutation analysis and no MCM was noted.   On 06-Nov-2018, at approximately 26 weeks of gestation, the mother was administered Flucelvax QIVc [influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, batch number: 252664, route of administration, anatomical location and expiration date: not reported] (explicitly coded as Foetal exposure during pregnancy') for an influenza immunization. On the same day, the mother underwent Q-natal test and no MCM was noted.   On 13-Nov-2018 and 07-Jan-2019, the mother underwent ultrasound scan and no MCM was noted.   At gestational age of 34.7 weeks, the mother delivered live female neonate by caesarean method. The characteristics of neonate included birth weight: 2041 grams, head circumference: 31.1 cm and length: 45 cm. Appearance, pulse, grimace, activity and respiration (APGAR) scores at one minute was 8 and at five minutes was 9. The neonate had no MCMs identified at birth.  At the time of initial reporting, the outcome of events low birth baby and premature birth were not reported.   The case was assessed as serious and the reporter did not provide causality assessment.   This case is linked to the case 201905142 (the corresponding mother case).; Sender's Comments: The female neonate subject was delivered as premature baby and low birth weight baby after foetal exposure during pregnancy with the suspect product Flucelvax QIVc. Chronology is plausible. The mother's medical history of extreme obesity (BMI) 53.8, gestational hypertension, yeast and placental abruption may provide alternative aetiology for the events. Causality was also confounded by therapy with concomitant drug, Terazol (terconazol). Foetal exposure during pregnancy is assessed as not related per company conventions. Considering all the above mentioned, causal role of the suspect product cannot be totally excluded and is assessed as unlikely related.
Patient passed away from chronic combined systolic and diastolic heart failure. This event was within 6 weeks of receiving the COVID vaccine.
Cellulitis of left arm from shoulder to 2" above elbow. Was given oral antibiotics instructed to call next day and return if not improving.
Patient reports he received 2nd Moderna vaccine on 4/4/21.  He presented to hospital on 5/10/21 with c/o dyspnea and was found to have a nonocclusive pulmonary embolism in right lower lobe. He denies long-distance travel,  history,  recent surgery/hospitalization. He believes PE was caused by COVID vaccine.
pt recv vax 5NOV98 8AM & 1030AM exp h/a, nausea, scratchy throat & flushed feeling;12:00 difficulty breathing, felt warm from chest & up, chest felt heavy;110PM eyes swollen, chest tight heavy, dyspneic, throat tight sore;
ache; Arm was very uncomfortable again; Sore arm at injection site and pains; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (Arm was very uncomfortable again), PAIN (ache) and VACCINATION SITE PAIN (Sore arm at injection site and pains) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sore arm at injection site and pains). On 15-Feb-2021, the patient experienced DISCOMFORT (Arm was very uncomfortable again). On 16-Feb-2021, the patient experienced PAIN (ache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and IBUPROFEN (ADVIL [IBUPROFEN]) for Pain, at a dose of 1 dosage form. At the time of the report, DISCOMFORT (Arm was very uncomfortable again), PAIN (ache) and VACCINATION SITE PAIN (Sore arm at injection site and pains) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was taken for cholesterol.
Pt. noted arm started to burn the evening of the vaccine. The next day 2-7-17 her Rt. arm was red, swollen, hot to touch and was itching. Tx with steroid cream.
Reported chills, shaking cold sweats throughout  the whole night, fever of 102F, body aches and abdominal pain.
PATIENT HAS BEEN VACCINATED TWICE WITH PFIZER VACCINE AND TESTED POSITIVE
On my way home, I started feeling like the left corner of my lips was getting swollen and burning a small bit and turning red.  Then I noticed a weird sensation in my throat and as time passed I had a harder time swallowing.  I had my husband drive me to the hospitals ER
Sore arm x2 days; This is a spontaneous report from a non-contactable other healthcare professional. A 25-year-old (unknown if pregnant) female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 22Apr2021 at 10:00 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was unknown whether the patient received any other vaccines within four weeks prior to the COVID vaccine. On 22Apr2021, the patient experienced sore arm for 2 days. 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 reported event. The clinical outcome of the event sore arm was recovered on 24Apr2021 after duration of 2 days.   No follow-up attempts are possible. No further information is expected
Right arm redness at injection site, low fever for 48 hours, malaise and fatigue.
I had Pfizer Covid vaccine in January (my fourth dose, with the first three doses of Moderna) and had quite strong reaction to the vaccine. Unlike the temporary symptoms from the first 3 Moderna vaccines, this time I continue to have very bad joints (almost all over the body, big and small joints) and muscle pain and fatigue for several months. First I thought that would be temporary but then I finally could not tolerate and saw my family doctor. The lab results showed high ANA and RNP level Diffuse Myalgias And Arthralgias, Positive ANA And RNP and I had to see a Rheumatologist. The symptoms have significantly affected my quality of life, work and family tasks. I would like to file a compliant about this vaccine especially for the boosters. There is lack of communication and timely update to patients/public about the risk of the vaccine, even there are more real-world data/evidence have been released in scientific world.
Extreme muscular stiffness in the mornings. Improves with activity, then returns upon prolonged sitting or reclining.
No additional AE's reported; Medical Assistant called to report that an expired dose of ROTATEQ was administered to a patient today, 10/21/22. Vaccine expired on 10/14/22. Patient has had no known side effects. It was confirmed with the medical assistant that the administered do; indicate at which point in the process the medication error ocurred: preparation for administration; This spontaneous report has been received from a health professional and refers to a 6-month-old female patient. The patient's medical history, concurrent conditions, and concomitant therapies were not provided.  On 21-OCT-2022, the patient was vaccinated with a expired rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, per prescribing information, lot 1742417, expiration date reported and internally validated as 14-OCT-2022, administered for prophylaxis (strength, and route of administration were not provided) (expired product administered). It was reported that there was a medication error in the preparation to administration of the vaccine (product preparation error). No temperature excursion was reported, and no additional adverse event.
8/4/99:Pt. rcvd vacc.8/31/99:pt. dvlped myalgia,fever,headache, fatigue,nausea,dec.appetite,jointpain,&dizziness.Dxed w/ hyper-eosinophilia & selective IgA deficiency.As of 12/14/99 pt. cont. to exper. headache,nausea,& fatigue.
HAD FLU FOLLOWING VACCINE SHOT. I EXPERIMENT CONTINUOUS (PM) JOINTS PAIN, MUSCULAR PAIN, SEVERAL HEADACHES, SKIN RASH ETC. SINCE 2003.
Shortness of breath; Chest pain; diaphoretic palms; fatigue; Nausea; dizzines; Arm Discomfort; Palpitations; muscle ache; CHILLS; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Arm Discomfort), PALPITATIONS (Palpitations), DIZZINESS (dizzines), HYPERHIDROSIS (diaphoretic palms) and DYSPNOEA (Shortness of breath) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Dysautonomia. Previously administered products included for an unreported indication: ALBUTEROL [SALBUTAMOL] (Albuterol inhaler 2 puffs PRN). Concurrent medical conditions included Asthma. Concomitant products included PROPRANOLOL for Dysautonomia.    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 LIMB DISCOMFORT (Arm Discomfort), PALPITATIONS (Palpitations), MYALGIA (muscle ache) and CHILLS (CHILLS). On 11-Mar-2021, the patient experienced DIZZINESS (dizzines). On 14-Mar-2021, the patient experienced NAUSEA (Nausea). On 15-Mar-2021, the patient experienced FATIGUE (fatigue). On 05-May-2021, the patient experienced HYPERHIDROSIS (diaphoretic palms) and CHEST PAIN (Chest pain). On an unknown date, the patient experienced DYSPNOEA (Shortness of breath). At the time of the report, LIMB DISCOMFORT (Arm Discomfort), PALPITATIONS (Palpitations), DIZZINESS (dizzines), HYPERHIDROSIS (diaphoretic palms), DYSPNOEA (Shortness of breath), CHEST PAIN (Chest pain), NAUSEA (Nausea), MYALGIA (muscle ache), CHILLS (CHILLS) and FATIGUE (fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information reported.   Most recent FOLLOW-UP information incorporated above includes: On 12-Aug-2021: Follow up document received and contains No New Information
Arm is tender; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 68-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included TETANUS TOXOID (TETANUS) for prophylaxis.   Previously administered products included Tetanus (booster dose was received in December 2011).   On 13th May 2019, the patient received Shingrix and TETANUS. On 14th May 2019, 1 days after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: On the day before reporting date, the patient was vaccinated with Shingrix. At the same time, the patient inadvertently administered Tetanus shot which was meant for another patient. The patient's arm was tender but generally the patient did not felt it too bad. It was unknown if the reporter considered the pain in arm to be related to Tetanus.  The patient also raised concern about the cost of Shingrix vaccine and information about adverse events associated with combination of Shingrix and tetanus vaccines given at the same time but the GlaxoSmithKline employee stated that, no information available about the combination of these two vaccines.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EM9809), in left arm, on 02Mar2021 as dose 2, single (Lot number: EN6200), in left arm and on 30Nov2021 as dose 3 (booster), single (Lot number: FD0809) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: High blood pressure; "Anxiety" (unspecified if ongoing); "high colesterol" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT, start date: Mar2021; METOPROLOL, start date: Jan2013; ROSUVASTATIN, start date: Sep2022, stop date: 02Nov2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient had a horrible very bitter taste in her mouth and was badly interfered with her ability to sleep. She had to suck Cepacol and make sure to numb my tongue to overcome the taste at night. The numb tongue only lasted for a short time and then she had to repeat to get back to sleep. She had very little sleep and feel drained, exhausted, and eat very little because food tastes terrible. In the daytime the patient discovered sipping constantly on milk helps. It was like torture at night. she had a relief after about 10 hours and it restarts about 2 hours after the next dose. The patient had no known allergies.
Few minutes after the vaccine patient was sitting on a chair. She fell to the side and dad caught her before she got to the floor. I ran out and we laid her on the floor. Her blood pressure was 108/82 and heart rate-88, her color had disappeared from her face for a minute and she felt better and breathing well after a minute or so. Ems arrived.
mom reported pt had sx on 26FEB93; called clinic referred to ER; mom did not take pt to ER; t102 ax post sz; given cool bath & APAP;
small lump under the skin at the first injection site; Itchiness at injection; Redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of LIPOMA (small lump under the skin at the first injection site), VACCINATION SITE PRURITUS (Itchiness at injection) and VACCINATION SITE ERYTHEMA (Redness at injection site) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 013L20Al) for COVID-19 vaccination.     Concomitant products included HCTZ and CARVEDILOL (COREG) for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2021, the patient experienced LIPOMA (small lump under the skin at the first injection site), VACCINATION SITE PRURITUS (Itchiness at injection) and VACCINATION SITE ERYTHEMA (Redness at injection site). At the time of the report, LIPOMA (small lump under the skin at the first injection site), VACCINATION SITE PRURITUS (Itchiness at injection) and VACCINATION SITE ERYTHEMA (Redness at injection site) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The treatment history was not provided. patient experienced rashes, pain at the injection site and a small developed in his hand symptoms come and go every two weeks, the patient not received treatment for symptoms.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: FU Received on 23-july-21,New events and event Outcome provided.
The patient was seen in the ambulatory care clinic for a vaccine follow-up. A pregnancy test was performed, however the patient was administered a Hepatitis A vaccine, HPV vaccine, and a medroxyprogesterone injection prior to the results of the pregnancy test. The pregnancy test was later confirmed to be positive.
PER ER FROM 09/05/2012: SWELLING AND ERYTHEMA FROM SHOULDER TO ELBOW, NO FEVER.
Missed 2nd dose/it has been 15 weeks since the first one; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose/it has been 15 weeks since the first one) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose/it has been 15 weeks since the first one). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose/it has been 15 weeks since the first one) had resolved.            No Concomitant and Treatment medication were not reported.
Patient stated headache and shaky feeling shortly after receiving vaccine around 3pm, symptoms worsening to throat tightness and chest pain, Epi 0.3mg given at 3:10pm in left thigh, VS slightly elevated at that time: B/P 156/92, HR 109, Temp 98.1, O2 sat 99%, RR 32. EMS called at time of Epi given, symptoms not improving at 3:18pm another Epi 0.3mg given in right thigh. Patient stated she received 1st dose of Janseen on 12/18/21 but symptoms were not this bad. Also stated had adverse reaction to Moderna on 4/13/21. Patient transported to nearest hospital and report given to EMS upon arrival at 3:20.
funny feeling/awful feeling; burning shoulder, down her arm that was injected, and down her back/burning sensation; her face was flushed; arm pain; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 72-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date was not reported), first dose via an unspecified route of administration administered on arm left on 11Feb2021 (at the age of 72 years) as single for an unspecified indication. Medical history included High Blood Pressure from an unknown date and unknown if ongoing. Concomitant medication(s) included diphenhydramine hydrochloride (BENADRYL) taken for an unspecified indication, start and stop date were not reported. On 11Feb2021 (Thursday) after vaccination patient was in the waiting room for ten minutes and started burning, like burning in my arm, my shoulder, all the way across the other shoulder and across the path on my neck. patient got her shot on the left side and that part of back was burning, so patient went to these 'EMS' (not clarified) guys and spoke with them and he looked down my shirt and he said yes, your back was red and it does not seems well. He said that patient could take Benadryl. So, she went and had Benadryl, as she had water in her car, on the way home patient took the Benadryl. When patient got home, she was great at about 8 o'clock and then studied book at 11. And then in the morning, 8 o'clock, she took another Benadryl and then my arm was hurting, so she took two Tylenol (treatment). next day was wonderful and okay. Yesterday, she was fine until about 3 o'clock and then this awful feeling came across her from head to toe then it was passed and then, the burning started again and burning was so bad at 8 o' clock that she took one Benadryl but it makes sleepy. Then in morning she got up at 7 and by 11 o'clock, the burning started again and now she was concerned because what about her second vaccine and how long will burning be and what can be done for it, perhaps see a doctor, and questioned about what can be done or was this a normal reaction to it. On unspecified date the patient underwent lab tests and procedures which included blood test, urine test and lab with unknown results. Patient was treated with Tylenol and Benadryl for adverse events. The outcome of the events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Tinnitus; Temperature; Body aches; Sweating; Headache; Nausea; Chills; This is a spontaneous report from a contactable other healthcare professional. A 40-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EJ1686) via an unspecified route of administration in the arm on 06Jan2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EH9899) via an intramuscular route of administration in the left arm on 18Dec2020 at 10:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. On 07Jan2021 at 21:00, the patient experienced tinnitus, temperature, headache, nausea, body aches, chills and sweating.The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.  Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On an unknown date, the patient underwent nasal swab test and the result was unknown. The clinical outcome of the events temperature, headache, nausea, body aches, chills and sweating was resolved on 09Jan2021 at 21:00, after the duration of 48 hours. The clinical outcome of the event tinnitus was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.