chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fetal pyelectasis; genetic testing ? showed caries of several; Ashkenazi genetic caries traits; Feotal exposure during pregnancy; This spontaneous report was received from a nurse practitioner referring to a currently 36 days old female patient. Information about medical history, concurrent conditions and concomitant therapies was not provided. The patient's mother was 33 years old. The patient's mother' last menstrual period (LMP) was assumed as 31-JUL-2019, date of conception was assumed as 14-AUG-2019. The patient's mother' medical histories included depression and treatments were given with bupropion hydrochloride (WELLBUTRIN) and citalopram.  On an unknown date, the patient's mother had a genetic testing during pregnancy which showed the patient had caries of several and had Ashkenazi genetic caries traits, and the patient had fetal pyelectasis.   On 26-FEB-2020, the patient's mother was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # 1602283, expiration date was reported as 16-AUG-2021, but upon internal validation established as 16-AUG-2021 in deltoid; strength and dose were not reported) and transplacental and diphtheria toxoid (+) pertussis acellular vaccine (unspecified (+) tetanus toxoid (TDAP) (1 ml, intramuscular; strength and dose were not reported) for prophylaxis (exposure during pregnancy, wrong product administered, product dispensing error, product administered to patient of inappropriate age and foetal exposure during pregnancy). The patient's mother' estimated due date (EDD) was 06-MAY-2020. On 07-MAY-2020, the patient's mother delivered a normal female baby at 40 weeks gestation.  The outcome of congenital pyelocaliectasis and dental caries was unknown. The outcome of foetal exposure during pregnancy was recovered. The causality assessment was not reported.   Upon internal review, congenital pyelocaliectasis was determined to be medically significant.  This case is crossed-referencing to 2003USA000105 (maternal case). combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1602283; expirationdate: 18-AUG-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2003USA000105:
This spontaneous report as received from a medical assitant refers to a patient of unknown age and unknown gender. On 10-MAY-2013 the patient was vaccinated with a dose of VARIVAX (Merck) lot # 666369/0226Z, expired date 28-JAN-2013 (dose, route not reported). No adverse effects reported. It was reported that potential mix expired VARIVAX vial with other VARIVAX vials in the same carton that were not expired. At the time of reporting, the patient's outcome was unknown. PQC was filed. Additional information has been requested.
shingles rash presented on Sunday on both sides of her torso; This case was reported by a consumer via call center representative and described the occurrence of shingles in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th September 2020, the patient received the 1st dose of Shingrix. On 13th September 2020, 1 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient reported that she received the vaccine on Saturday and a shingles rash presented on Sunday on both sides of her torso. The reporter consented to follow-up.
swelling; allergic reaction related to vaccine because I've never had a problem with Bacitracin before; rash; pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (allergic reaction related to vaccine because I've never had a problem with Bacitracin before), RASH (rash), SWELLING (swelling) and PAIN IN EXTREMITY (pain in arm) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (pain in arm). On 08-Mar-2021, the patient experienced HYPERSENSITIVITY (allergic reaction related to vaccine because I've never had a problem with Bacitracin before) and RASH (rash). On 09-Mar-2021, the patient experienced SWELLING (swelling). On 05-Mar-2021, PAIN IN EXTREMITY (pain in arm) had resolved. At the time of the report, HYPERSENSITIVITY (allergic reaction related to vaccine because I've never had a problem with Bacitracin before), RASH (rash) and SWELLING (swelling) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient believes the allergic reaction to Bacitracin could be related to the Moderna Covid-19 vaccine. She reports that she applied Cortizone cream to help with the itching but the symptoms are ongoing. Treatment details included Bacitracin topical ointment, Cortizone cream.
Pain at injection site 1 hr post shot, 02:30pm. 4:30-5pm pain on whole arm, 7pm pt went to ER with convulsion.
Subject 16 year old was inadvertently given a DTap vaccine, this vaccine is recommended under the age of 7 years.
I had to go to Emergency Room on 02/09/2022.  During some routine lab tests, they found out I now have a very elevated D-Dimer result at 293.  I may have even had a small pulmonary embolism, they were not sure.  I also had to go back on 04/18/2022 and my D-Dimer was even more elevated at 376! It has never been elevated before my first booster, or my third vaccine.
Area of injection got hard-purple and hot was advised by MD to use ice. Took Tylenol. Applied ice several times a day for 2-3 days.
Flu shot given (L) deltoid on 10-16-12. Redness, warmth, pain at injection site the following day. No other symptoms. Evaluated 10-18-12 - erythema, warmth 12x15cm area (L) upper arm. No fever or other complaints. Improving today.
Area of 4" diameter became red, swollen and feverish to touch after 24 hrs. After 48 hours her arm was numb/tingling. Noticed improvement after 72 hours and now resolved.
muscle pains and muscle tinglings in the left arm bicep and both feet area; muscle pains and muscle tinglings in the left arm bicep and both feet area; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 38-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Mar2021 (Batch/Lot number: unknown) at the age of 38 years as dose 1, single for COVID-19 immunization. Relevant medical history included: "Hypothyroid" (unspecified if ongoing). Concomitant medication included: LEVOTHYROXINE. The following information was reported: PARAESTHESIA (disability), MYALGIA (disability) all with onset 12Mar2021, outcome "not recovered" and all described as "muscle pains and muscle tinglings in the left arm bicep and both feet area". The event "muscle pains and muscle tinglings in the left arm bicep and both feet area" and "muscle pains and muscle tinglings in the left arm bicep and both feet area" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood test: did not show anything; electrocardiogram: did not show anything. Therapeutic measures were taken as a result of paraesthesia, myalgia which included Oral treatment. Clinical course: My body started changing after the COVID vaccine in early March. I stated some muscle pains and muscle tinglings in the left arm bicep and both feet area which I didn't have earlier. EKG and blood tests did not show anything. Later, I started observing several changes in my body.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Headache; Breathing difficult/Trouble Breathing; Nausea/Sick to stomach; Rheumatoid arthritis; Arthralgia aggravated; COVID-19; This is a spontaneous report based on the information received from a contactable consumer by Pfizer (Mfr Control No#: 21K-163-4051052-00). A 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration date were not reported), intramuscularly in Jan2021 at dose 1, single and in Feb2021 at dose 2, single for COVID-19 immunisation; abatacept (ORENCIA), via an unspecified route of administration from 2011 (Lot number was not reported) to an unspecified date, at unspecified dose for an unspecified indication; adalimumab (HUMIRA), subcutaneously from 2011 (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for an unspecified indication. The patient medical history and concomitant medications were not reported. Patient previously had major problems on Methotrexate, specifically pain all over body could not get out of bedridden. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient experienced covid-19 in Dec2020, arthralgia aggravated in 2021, had rheumatoid arthritis, headache, breathing difficult/trouble breathing, nausea/sick to stomach. The outcome of the events was unknown. The causality between Pfizer vaccine, Humira (Adalimubab) and events was not provided  Information on the lot/batch number has been requested.
pt recv vax 14SEP92 & 16SEP92 pt exp fatigue & became lethargic;pt stopped talking gradually & w/in a month began banging head;pt had fever off & on;immunological work-up indicated pt immune system fell apart;
Broke out in hives on arm where injection was given and chest. Relieved w/ 2 Benadryl.
Second dose given 3/16/2021 to 17 year old.  First dose given 2/16/2021 reported to VAERS and Safeway Corporate.
Extreme swelling and redness at injection site. Patient went to ER and received BENADRYL by mouth and topical as treatment.
Headache, Sedation, Arthralgia, Fever & NauseaVomiting Narrative:
Information has been received from the nurse, reported that PROQUAD (lot # J004321, Expiration date 17-OCT-2014 and VARIVAX (Merck (captured in MARRS# 1311USA002616) went through unsupported temperature excursion on 26-JUN-2013, 01-JUL-2013, 22-JUL-2013 thru 31-JUL-2013 and the entire month of August 2013. On 04-SEP-2013 one patient (age and gender not reported) was administered the unsupported PROQUAD (dose and route not reported). No adverse effects reported. This is one of several reports received from the same source (MARRS# 1311USA012185, 1312USA003399, 1312USA003401, 1312USA003306, 1312USA003307, 1312USA003308, 1312USA003309, 1312USA003310, 1312USA003311, 1312USA003312, 1312USA003313, 1312USA003314, 1312USA003315, 1312USA003316, 1312USA003317). Additional information has been requested.
Pt vomited several times between 3AM & noon 10JUL91 highest measured t102; Called MD who advised pedialyte & flat coke; Stated vomiting was probably not due to immun;
Patient called the pharmacy on 11/29/2018 reporting feeling itchy and starting to break out in a rash. I counseled the patient on both signs of a reaction, minor and major allergic reaction. Patient was instructed to take BENADRYL or a antihistamine in the meantime.
Information has been received from a registered nurse concerning a patient who on 22-JUN-2012 was inadvertently vaccinated with a dose of improperly stored MMR II (lot# 670621/0568AA, expired on 15-APR-2012). No adverse effect reported. It was unknown if the patient had sought medical attention. This was one of the several reports received from the same source. Additional information has been requested.
Right after immunizations, she fainted and became incontinent of urine.  Came to quickly but complained of headache and stomachace and appeared confused.  More lucid after about 1 hour.  Vomited about 3-4 times next few hours.  Better the next am.
VOMITED AFTER LAST DOSE OF VIVOTIF; This spontaneous case (PVX2019-1492) was received from a pharmacist on 10-Jun-2019. It describes a female consumer who "vomited after last dose of Vivotif". The consumer was receiving Vivotif for an unknown indication.  Case report: The consumer took the last dose of Vivotif on Friday. On Saturday, in the middle of the night, she threw up. However, she did not vomit any more afterwards. Also, she did not take any treatment for it.  The consumer's medical history included bipolar disorder.  The consumer did not take any concomitant medication.  Action taken with Vivotif was not applicable.  The consumer had recovered from the event.  Company's Comment: In this case, it was reported that the consumer vomited after last dose of Vivotif. There seems to be a temporal association between the intake of vaccine and the event. Also, vomiting is labelled as per agency. Hence, the causality of the event with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that the consumer vomited after last dose of Vivotif. There seems to be a temporal association between the intake of vaccine and the event. Also, vomiting is labelled as per agency. Hence, the causality of the event with Vivotif is assessed as possible.
Visit Type:  Acute Visit CC:  poss shot reaction.  History of Present Illness: Pt c/o poss reaction to Tdap recieved friday. States joint pn began in knees friday PM and has moved up the body, progressively getting worse. Pt c/o SOB, HA, N&V, and a general weakness.  Acute Visit History: The patient complains of headache and vomiting.  She denies cough, diarrhea, and fever.    Past Medical History: Reviewed history from 07/16/2008 and no changes required: MIGRAINE (ICD-346.90), FEMALE INFERTILITY (ICD-628.9), OBESITY (ICD-278.00), METABOLIC SYNDROME X (ICD-277.7), HYPERLIPIDEMIA (ICD-272.4), BACK PAIN (ICD-724.5), UTI (ICD-599.0)  Family History: Reviewed history from 05/14/2009 and no changes required: FH Alcoholism, FH Heart disease, other, FH Hyperlipidemia, FH Hypertension, RA - father, aunt and grandfather  Social History: Reviewed history from 04/28/2009 and no changes required: Married, Homemaker, 3 kids  Risk Factors:  Tobacco use:  never Passive smoke exposure:  yes Drug use:  no HIV high-risk behavior:  no Caffeine use:  0 drinks per day Alcohol use:  no Exercise:  yes    Times per week:  3    Type:  stationary bike Seatbelt use:  100 % Sun Exposure:  occasionally  Family History Risk Factors: Family History of MI in females < 65 years old:  no, Family History of MI in males < 55 years old:  yes  Vital Signs: Patient Profile: 37 Year Old Female Height: 65 inches (165.10 cm) Weight: 243.4 pounds (110.64 kg) BMI: 40.65 Temp: 98.6 degrees F (37.00 degrees C) oral Pulse rate: 76 / minute Pulse rhythm: regular BP sitting: 118 / 78  (left arm) Cuff size: large  Physical Exam General: appears ill but non-toxic.   Ears: TM's and ear canals normal;  Nose: nasal mucosa normal;  Mouth: mouth and throat clear;  Neck: no masses or abnormal cervical nodes;  Lungs: breathing non-labored, clear to auscultation bilaterally;  Heart: regular rate and rhythm, normal S1/S2 without gallop, murmur, click or rub;  Neurologic: DTR's 1+ B at patellar  Impression & Recommendations: Problem # 1:  MYALGIA (ICD-729.1)  Her updated medication list for this problem includes: Advil 200 Mg Tabs (Ibuprofen) ..... 1-2 by mouth with food or milk prn Hydrocodone-acetaminophen 5-325 Mg Tabs (Hydrocodone-acetaminophen) ..... 1-2 by mouth every 4-6 hours as needed for pain Cyclobenzaprine Hcl 10 Mg Tabs (Cyclobenzaprine hcl) ..... 1 by mouth 3 times a day as needed for muscle spasm or pain  Orders: CBC w/diff (CPT-85025), CMP (CPT-80053), Sed Rate (CPT-85651), CPK (CPT-82550), 99214 Detail (CPT-99214)   Patient Instructions: 1)  Return to clinic as needed. Precautions given regarding worsening or nonresolving symptoms. To ER if sig worse Prescriptions: HYDROCODONE-ACETAMINOPHEN 5-325 MG TABS (HYDROCODONE-ACETAMINOPHEN) 1-2 by mouth every 4-6 hours as needed for pain  #20 x 0
pain all the way down to wrist; diizziness was very bothersome, had to lie flat to feel better; Backache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain all the way down to wrist), DIZZINESS POSTURAL (diizziness was very bothersome, had to lie flat to feel better), BACK PAIN (Backache) and NAUSEA (Nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain all the way down to wrist), DIZZINESS POSTURAL (diizziness was very bothersome, had to lie flat to feel better), BACK PAIN (Backache) and NAUSEA (Nausea). At the time of the report, PAIN IN EXTREMITY (pain all the way down to wrist), DIZZINESS POSTURAL (diizziness was very bothersome, had to lie flat to feel better), BACK PAIN (Backache) and NAUSEA (Nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient did not seek medical treatment.
Lymph node on left side, pain under armpits,  body ache, sore throat and dairrhea
Information has been received from a physician's assistant concerning her daughter (age unknown), who, on an unspecified date was vaccinated with a third dose of Gardasil.  Subsequently, "within 24 hours post vaccination" the patient experienced "significant muscle aches and a low grade fever."  The patient did not seek medical attention.  The patient recovered on an unspecified date.  No product quality complaint was involved.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 10/12/2007. Information has been received from a physician's assistant concenring her 25 year old daughter, who, on an unspecified date was vaccinated with a third dose of HPV vaccine. Subsequent;y, "within 24 hours post vaccination" the patient experienced "significant muscle aches and a low grade fever." The patient did not seek medical attention. The patient recovered on an unspecified date. No product quality complaint was involved. Additional information has been requested.
Itching on the arm  (started within the first hour) and sore and my arm felt heavy (injection site arm). Hard to lift my arm. I noticed my fingers were swelled up. The itching never has gone away. I still get it. The swollen fingers took about two weeks to go away. I hadn't been able to take my wedding rings off. Heaviness didn't go away. When I got the second shot that got worse (heaviness). March 28 was date of second Pfizer vaccine - LOT# ER8730. The itching felt more prominent and I couldn't scratch by that time so I would try to rub it lightly to calm it. I would put warm compresses on my arm jus to fall asleep. I went to the doctor - I had to see a resident doctor in the office - that might have been 6/2/2021.  He prescribed me to take two Aleve's morning and night. And he prescribed a muscle relaxant and Naproxen but none of that worked. I can't extend my arm unless I use my other arm to do it. It wakes me up at night. They also prescribed physical therapist and I had my second Physical therapy appt yesterday but it just hurts - they have scheduled me for12 sessions. I had realized there was a lump on the arm on the first week of May. Now the lump is bigger and you can feel hardness inside. Doctor could see it. The lump is a little lower to the right of the injection site. If I put my three middle fingers together it kind of covers the size - so it's the width of three finger. And that hurts - it wakes me up at night even if I'm not sleeping on it. I'm usually pretty tolerant of pain and I don't usually have time to go to the doctor but this is how bad it hurts - I had to go to the doctor. My physical therapist says they have had patients come in with those same symptoms after their vaccines. I also get lightning bolt pain on the left side of top of my hand - on my left hand. It feels like a neurological issue.
The day of the vaccination, my face was a deep red. The morning after the vaccination red spots appeared on my face and I had a small red spot at the injection site. The red spots on my face went away however the injection site redness grew significantly, became very hot and I am currently at 5 days past the injection The swelling and redness has grown to cover my upper arm from shoulder to elbow area, the redness and swelling is hot to the touch. I have red spots on the lower part of the injected arm. Additionally I am experiencing soreness in my underarm area on both sides and suspect swollen lymph nodes.
14 hours after getting the vaccine, I had rapid onset fever with Tmax 104F, chills, rigors, headache, nausea, and myalgia. This lasted nearly 4 hours and then spontaneously resolved without intervention.
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 69-year-old female patient who received SHINGRIX for prophylaxis. On 2nd October 2018, the patient received the 1st dose of SHINGRIX. On 2nd October 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema and injection site swelling. On 3rd October 2018, the patient experienced fever. On 4th October 2018, the patient experienced numbness of upper extremities. In October 2018, the patient experienced injection site discoloration. In October 2018, the outcome of the injection site discoloration was recovered/resolved. On an unknown date, the outcome of the injection site erythema, injection site swelling, fever and numbness of upper extremities were recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site discoloration, fever and numbness of upper extremities to be related to SHINGRIX. Additional details were provided as follows: The patient experienced redness and swelling at the injection site the same day that she had the injection and it lasted about a week. Then the site of injection was discolored from red to brown. That discoloration was gone at the reporting time, but it tooked a long time to go away. The patient experienced fever the day after the injection and it lasted a half a day. The patient experienced numbness in her whole arm where she received the injection and it lasted over a week and then it went away. The patient had denied permission to contact their physician.
My son nearly died from the vaccine, he suffered abdominal pain, and sever vomiting for 5 days, a he has only this evening had a mouthful of supper he has lost all taste,  he innoculation last Tuesday, so it's over a week he has had nothing to eat for fear of continues vomiting, we could not go to a doctor or the clinic as he was in to much pain to drive the car, so yesterday my sister brought him some medicine from the chemist, only started to feel a little bit better today, I nearly lost my son because of this bloody vaccine.