chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse through the Merck pregnancy registry concerning an 18 year old female with a family history of diabetes mellitus and familial risk factor (gestational diabetes mellitus, and pre-eclampsia in patient's mother), who on 14-SEP-2007 was vaccinated with her first dose of 0.5 mL GARDASIL (lot #658554/0928U). The patient is now 8 weeks pregnant with last menstrual period 04-Sep-2007 and an estimated due date of 11-JUN-2008. There is no information about the vaccine because it was given at another office. The patient sought medical attention with an exam in the office. Follow up information has been received from the obstetrician/gynaecologist who reported that on 08-JAN-2008, the patient underwent an ultrasound indicated for gestational diabetes mellitus (GDM) and polyhydraminos which showed polyhydraminos. She also had a serum alpha-fetaprotein test, indicated for (GDM) and polyhydraminos, which was negative. On 31-MAR-2008, 09-MAY-2008, 15-MAY-2008 and 30-MAY-2008 the patient underwent ultrasounds indicated for (GDM) and polyhydraminos, all showed polyhydraminos, but otherwise normal. A 35 glucose tolerance test done during the pregnancy was abnormal -1. Gestational diabetes was diagnosed (date not reported). The treatment for the gestational diabetes mellitus included insulin NPH BID and insulin regular daily. The physician reported that the patient underwent several neonatal stress tests (dates not specified) which were normal and reactive. The patient also experienced pre-eclampsia during her pregnancy (date not specified). The physician reported that on 06-JUN-2008, at 38 5/7 weeks from last menstrual period, the patient delivered a normal male infant with apgar: 9/9, weight: 7lbs 11ozs, length: 21 inches, and head circumference: 37 cm. The infant had mild jaundice. Additional is not expected.
15 minutes after vaccine patient developed dizziness, left sided cheek numbness and tingling, headache and nausea. Felt as though he was swallowing  a ball in his throat. BP elevated after vaccine at 170/102 but decreased to 140/98 15 minutes later. Symptoms did not worsen and patient was taken to health clinic onsight to be seen by NP and monitored. No SOB or chest tightness. Advised patient to contact PCP to discuss further vaccination. Advised on signs and symptoms to monitor for.
Reports redness at injection site 5cm x 3cm with itchiness and mild pain. Noticed redness 1/30/23 in morning.
Information has been received from a county health registered nurse concerning a 6 year old patient who on 12-Jan-2002 was vaccinated with varicella virus vaccine live (Oka/Merck). On 12-MAR-2007, the patient developed varicella, < 50 lesions. The nurse reported that an outbreak of varicella had taken place in the local school district April 2007, and this student was identified during the county health investigation. An immunization clinic was conducted in the school where students received a second dose of varicella virus vaccine live (Oka/Merck). this is one of 28 reports received from the same source. No further information is available.
Hives on buttocks, legs, hands, elbows that is itchy. Began 10:00 PM on 02/18/05, 4 days after vaccines were given. Went to ER, Benadryl, Epi and cotrisone given. Continues to take medication for itching. Given Zantac, Claritin and medrol pack.
ADMINISTERED EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 55 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 201A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-SEP-2021, the patient experienced administered expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20211038507, 20211038269, 20211039749, 20211039732, 20211002617, 20211038442, 20211038411, 20211038664, 20211034734, 20211038276 and 20211038664.
On 11/13/02, patient noticed testicular swelling. Patient noticed both testicles were swollen; the right one was about 25% larger than left. Patient states he waited approximately 2 days after shot to go to doctor. Patient was then treated with Levaqin 1 per day for approximately 7 days. Patient states approximately 4 days after shot a pea sized bald spot on the left front of scalp. Patient states he noticed on about 11/21 or 11/23/02 the bald spot had spread about 3/8" of an inch in diameter. Bald spot as of this date spread to approximately 1x1 inch in size. Patient was given lotrimin solution to apply to site 2 times a day. Today, patient has not yet applied topical solution.
difficulty of swallowing feeling food stuck at throat and painful anterior chest Follow-up Information 26-JAN-2010: Thank you very much. I like to inform you that I am the patient who received the H1N1 vaccine at the hospital. I have no recall of any prior symptoms of odynophagia nor dysphagia prior to the the vaccination I am currently suffering from continuous sore throat for the last 2 1/2 months you can contact me at my office I just finished this am a test at the university for tonometry of the esophagus, I am scheduled to have a videofluoroscopy tomorrow, and next week I shall have a Bravo capsule to evaluate the possible reflux which I believe is due to the loss of tone of the lower esophageal sphincter after the flu shot I don't recall having any prior symptoms of reflux nor any problem with swallowing prior to the injection I shall forward the information you want after is completed.
This spontaneous report was received from a physician and refers to multiple patients of unknown age and gender. Information on the patients' concurrent conditions, medical history or concomitant therapy was not reported. On an unknown date, the patients were vaccinated with M-M-R II (lot # L039613, expiration date: 08-OCT-2017, dose and route of administration ere not provided) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
No adverse event. We picked up what was supposed to be COVID-19 Moderna vaccine. Lot numbers and expiration date matched tracking sheet given to us by the agency. Color of medication also matched what was stated on Fact Sheet for Healthcare Providers and regulatory authority website for the Moderna vaccine. Instead, the medication in the vial was actually COVID-19 antibodies meant for hospital use. After administration for 44 individuals, we received call from the agency that the medications had been mixed up. The vials and box that medication came in had no identifying factors to indicate it was not the Moderna vaccine.
i got a giant hive and it was hot to touch and it was raised, it was itchy and hurt to itch, reduced in 4 days. 9inches long 5 inches wide. The doctor told me to take Benadryl
56 year old female with SLE received injectable. Pt experienced hives and facial swelling 1 day after vaccine. Symptoms lasted 7 days. Pt did not seek care. Resolved by 10 days post-vaccination. We have been unable to reach this patient despite repeated attempts.
Puffy and swelling fingers and tongue.  Reported puffiness of hands/fingers and swelling tongue.  Complain of mild tightness in throat.  BENADRYL 25 mg given times 2, 1 hour apart.  Returned to work.
Order written for 0.50 mL Afluria, box had a dose of 0.7mL High dose Fluzone.  The Fluzone was give to the Patient.  Pt was informed and Provider was informed.
This child was diagnosed with advanced epilepsy at the Clinic after progressive neurologic decline, starting 2 weeks after these 2 vaccinations were given. She was ultimately started on anti-epileptic drugs to stop the 10+ seizures she was having daily.
At 10:40, the patient went in for her first Moderna vax.  She was slightly nervous since she's not a fan of needles. When she got it a vessel must have been nicked, because she experienced a bit of blood streaming down her arm which surprised us. The nurse wasn't concerned and stopped it quickly and cleaned up her arm.  Got her a new bandaid and she was sent to the chairs in the waiting area to wait her 15 minutes following the vax.    I had to pick up my regular prescription so I got in line while she was sitting there surfing on her phone.  As I got to the front of the line, the patient called me and said she was feeling lightheaded. I immediately left the line, and was there (I was maybe 15 feet away) and was asking how she felt. She said she felt sweaty and like she might pass out.  Right then, her eyes rolled a bit and closed and she went limp. I was able to hold on to her and a customer that was behind me in line and I were able to alert the nurse that gave the vax and the pharmacist. Both immediately came to our aid.  We got the patient on the floor and on her side.  The nurse wanted us to have an epi pen in case, but we all didn't think it was an allergic reaction. We checked her blood pressure and it was low.  Another employee was already calling an ambulance and another was getting her some juice. She was beginning to regain consciousness. She was only out for about 2 to 3 minutes at the most.  Her blood pressure was low, but started to come back to normal pretty quickly.  We had her lay there a few minutes and then sit up. Eventually we moved her to the chair a few minutes later.  Within another few minutes the emts arrived. She had already had answered questions for us like her name, birthday, where she was, etc.  The emts repeated those same questions, asked us what happened and rechecked her vitals.  All were back to normal.  They gave her the option of be transported to the ER, but given that she was feeling back to normal she declined and everybody felt good about that decision.
Two days after sore shoulder muscle. October 12, 2022 had injury with torn rotator cuff.
A nurse reported a 2 month old pt (gender not specified) received a 1st injection of Prevnar and Tripedia, IPV and Comvax on 5/16/01. Within 12 hors, the child developed a fever of 102F-103F, fussiness and loss of appetite. At that same time, the child developed an injection site reaction characterized by redness and swelling. This is one of 3 identifiable pts from this reporter who experienced events following receipt of Prevnar lot 474724. For information on the other 2 pts see HQ1115021MAY2001 and HQ1206522MAY2001. The reporter was unable to specify additional pts involved. Additional reports will be generated when identifying information is provided.
Within minutes of receiving vaccinations child developed approx 1/2 inch raised hive above MMR injection site. Area of redness enlarged to about 1.5-2 inches. Child undressed and monitored. No respiratory distress. TC to 911 made at 1:27 PM. 0.25 ml Benadryl IM given in LL at 1:36 PM. Ambulance team arrived 1:42 PM. No further changes at injection site noted. Child transported with mother via ambulance to hospital. 7/3/03 F/U TC to child's mother. Child evaluated at ER and he was given a "steroid liquid". Child discharged home. Mother instructed to give Benadryl every 6 hours for 3 days and continue to monitor respirations and for hives. Mother reports child is doing well.
Took Anthrax shot 02/04/2003, was ordered to do so.  Nurse shown medical documentation of condition.  Immediately after Anthrax shot, I got light-headed, later that evening I felt like my head would blow off from so much pain.  It aggravated pre-existing heart condition and I ended up in hospital for the first time for this condition.  Have had cold/flu like symptoms from this date until now since taking shot.  Now 05/15/2003.  Also now suffer from numbness of whole left side left arm and left leg especially. Per review of hospital records, dystonia is added to adverse event. Follow up 01/20/05: I have not recovered from the adverse event. I have developed fibromyalgia since the anthrax vaccine. I have an array of symptoms including: vision changes, pain all over, back problems, fatigue, trouble sleeping, stomach problems, numbness and tingling of my extremities, etc. There are times the pain is so intense, movement is hart (difficult). This vaccine is not safe. Almost 2 years later I am still suffering. My life has been changed.
pt called on 12DEC94 states arm was sore evening p/flu vax given in lt deltoid; progessively got worse for several weeks; currently arms is swollen, warm to touch, w/restricted mobility due to pain; referred to PMD for treatment;
My blood pressure is going high; my wrist and heart is 90 and 91; This is a spontaneous report from a contactable consumer or other non health care professional (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 24Aug2021 14:30 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 24Aug2021 at 14:30, the patient's blood pressure was going high and wrist and heart was 90 and 91. The patient got the Pfizer Vaccine like 14:30 today and now patient's blood pressure was really high like patient's wrist and heart was 90 and 91. The patient underwent lab tests and procedures which included blood pressure measurement: high on 24Aug2021 going high, heart rate: 90 and 91 on 24Aug2021. The outcome of the event "My blood pressure is going high" was not recovered and outcome of "my wrist and heart is 90 and 91" was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up attempts have been completed and no further information is expected.
This case involves an unknown age and unknown gender patient who experienced bad cold for about 7 days it put me in the bed (nasopharyngitis) after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious bad cold for about 7 days it put me in the bed (nasopharyngitis) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Booster ok laid around 2days later go flu shot ended up with bad cold for about 7 days it put me in the bed."  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.  There will be no information available on the lot number for this case.
This study case was received from the investigator on 22 February 2012. An unidentified subject whose medical history was not available was found to have on 29 April 2011 an acute myocardial infarction, subendocardial infarction after the subject had received an injection of ACAM2000 (lot number, route, site and date of administration not reported). Relevant laboratory tests and treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Patient started with maculopapular rash on fact that then progressed to petechia on her face, scalp, ears and neck along with maculopapular rash on trunk and lower extremities 10 days after vaccination. No fevers, no nausea, vomiting or diarrhea, no altered mental status, no seizure, no mucous membrane involvement, rash spares palms and soles. Patient was otherwise well and acting appropriately despite rash.  Treatment- given petechia and reports of ITP after MMR CBC was ordered. Benadryl prn was started for itching, and follow up in 2 weeks. Return precautions discussed with parent Outcomes - unavailable yet
24-36 hours after injection patient with significant soft tissue swelling over right deltoid right sup shoulder and left lat neck with one swollen tender lymph node supraclavicular.
2 days after injection, cheeks were bright red. 1 day later, arms, legs and torso broke out in rash that itched. BENADRYL every 4 hours to control itch.
AFTER INJECTION GOT FEVER, NORMAL, NEXT DAY I STARTED TO GET RINGING IN MY EARS, SAW PRIMARY PHISIISON AND HE SAID IT WAS FROM THE VACCINE, RINGING IN EARS FOR 11 DAYS NOW, CAN'T SLEEP, THINK, WORK, SCHOOL, ALL EFFECTED.
Unknown. Was informed that the patient went to E/R on 1/25/21 (6 days after receiving vaccine. Died 1/29/21 ( 10 days after receiving vaccine).
Flu like symptoms after covid vaccination on 2/2/2021. Patient developed chills, headache, fatigue, body aches during HD. BP remained stable < 100 systolically which is relatively good for patient. He remains afebrile. He notes right arm discomfort and is cold with chills. He notes headache is generalized with no changes in vision, no dizziness, no numbness / paresthesias noted. He denies n/v/d/c, no dyspnea or chest pain, no sore throat. No loss of taste or smell. On  2/3/2021 at about 2pm patient developed fever, hypotension and tachycardia.Recevied 1 liter of NS infusion. Team decided to transfer pt to OSH for further evaluation.
Pt. got lightheaded and a little nauseated about 10 - 15 min after getting FLUVIRIN shot. We sat her in a chair and she drank a bottle of water until feeling better. Told her to stay in store until feeling normal again.
Immediate onset of headache, extreme fatigue, difficulty sleeping, felt like she had the flu and muscle spasms in the left arm - which has persisted to this day.  Subsequently have severe cramping, PMS symptoms, bleeding, irregular cycles and duration of periods.  Persistent fatigue with brain fog, and chronic fatigue.
1hr p/vax pt exp pins & needles feeling all over;nausea;numb tongue;no rash;fullness in ears;tx w/DPH;anxiety/possible allerg rxn;
Allergic reaction / Rash all over body / Sores in mouth / throat began closing and began having trouble breathing approx. 4  hours after injection.
This spontaneous report as received from a health care worker refers to 13 unspecified patients of unknown demographics. Patients medical history and current condition was not reported. It was reported that since unknown date improperly stored VARIVAX (Merck) (Lot number and expiry date not provided) vaccines were administered to the patients. No adverse effects noted. Product quality complaint was not reported. The outcome of the event was unknown. Additional information has been requested.
This spontaneous report was received from a physician referring to 19-month-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications or drug reactions or allergies was provided. On 10-JUN-2017, the patient was vaccinated with an improperly stored dose of VAQTA (lot # N005274 and expiration date 03-APR-2018; dose and route of administration were not reported) for prophylaxis. It was reported, that on several dates between 25-APR-2017 until 07-SEP-2017, the vaccine was exposed to various temperature excursions ranging from 32 degrees Fahrenheit (F) to 54F for the period of up to 70 hours at a time. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter.; Sender's Comments:  US-009507513-1709USA012768:
CLIENT WAS GIVEN DTAP-POLIO-HEPB VACCINE, POLIO VACCINE, AND HEPB VACCINE IN ONE VISIT. ERROR WAS REPORTED TO MOM AND TO VACCINE ERROR REPORTING PROGRAM. MOM CALLED ON 02/25/15 TO CHECK IN ON CLIENT. MOM STATED CHILD HAD HAD A LOW GRADE FEVER AND MUSCLE SORENESS AFTER VACCINATION AND DENIED ANY COMPLICATIONS RELATED TO VACCINE ADMINISTRATION ERROR.
She stated three days after the second dose she developed a blood clot; whole leg is numb; so much pain; For three months she has had no life and unable to work.; Bedridden since the second vaccination of the Pfizer; This is a spontaneous report from a contactable consumer (patient's sister). A female patient of an unspecified age received bnt162b2 (BNT162B2, formulation: Solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (BNT162B2, formulation: Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported), as single dose for COVID-19 immunisation and experienced no reactions after the vaccine. On an unspecified date, three days after the second dose of vaccination, the patient developed a blood clot, whole leg was numb, so much pain and for three months she had no life and unable to work. It was reported that the patient was bedridden since the second vaccination of the Pfizer. The clinical course of the events as follows: the reporter stated that her sister who had been bedridden since the second vaccination of the Pfizer Vaccine. She stated three days after the second dose she developed a blood clot, her whole leg was numb. She has had so much pain and it had been three months now. It was reported that she was not blaming the vaccine for this. However, she was calling to find out if there were other complaints of this happening, so she could let her sister physicians know. For three months she has had no life and unable to work. Reporter stated that she was worried about her sister physical and mental health. The outcome of the events was not resolved at the time of this report.  Information about lot/batch number cannot be obtained. Additional information has been requested.
Stuffy nostrils, sneezing, chills & sweat, head pain, shortness of breath, body aches 2 day duration.
vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment medication was provided.   This case was linked to MOD-2021-395985 (Patient Link).
Case number PHEH2016US031315, is an initial spontaneous report received from a pharmacist on 07 Oct 2016 (combined report). This report refers to an adult female patient. Medical history and concomitant medication were not reported. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer unknown and batch number: not reported) on an unknown date 04 years ago. After vaccination, the patient had reaction to flu vaccine (unknown reaction). The outcome of the event was reported as unknown. The seriousness and causality of the events was not reported.
After Thursday 2/25/21 developed soreness in arm and neck on same side of injection. Next morning Friday 2/26/21 developed body aches, low grade fever (99.4) and numbness in left upper lip for about and hour and a half. Chills and fatigue present as well. Unable to work at job.