chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from registered nurse concerning to a 69 year old female patient. The patient's concurrent conditions included hypertension and hyperlipidaemia. The patient was currently a tobacco user. The patient's medical history was not provided. The patient's concomitant medications included atorvastatin, calcium carbonate, vitamin D and ASTELIN. On an unspecified date, the patient experienced allergy to lisinopril (captured in MARRS # 1704USA003065). On 27-MAR-2017, the patient was vaccinated with PNEUMOVAX 23, intramuscular (strength, dose, lot number and expiration date were not reported) for prevention of pneumonia.  On the same date, by the evening, the patient had started to experienced redness and 10 to 10 of pain. The patient experienced a cellulitic reaction from the right shoulder to the elbow, bright red and blistered, fire engine red, warm and tender to touch. The patient went to the doctor's office on 28-MAR-2017 (reported as today) and she was seen by an unspecified physician. The physician ordered a prednisone taper pack, BENADRYL, famotidine (manufacturer unknown) and halobetasol cream. No laboratories or studies were done. At the time of reporting the outcome for the event was unknown. Upon internal review the cellulitic reaction was considered to be a medically significant event. The reporting nurse considered the cellulitic reaction as significant disabling because of the lack of function of the right arm. The causal relationship between the event and the vaccine was not provided. Additional information has been requested. Sender's Comments:  US-009507513-1704USA003065.
Got vax 3:40 P-woke up 1:30 A, T 104, vomited. Went to ER-gave IV after 2nd vomit episode then temp was 100 degrees-was given TAMIFLU q 12 hours-attends elem. school. (Middle school had H1N1 outbreak this week).
My arm was sore and stiff for a couple days after and at around 4 day mark hard for me to even lift my arm. Started massages and exercises to work it out. At 6 months. still had an issue and went to see the doctor. Physical Therapy was prescribed and referred. Currently feeling better but not out of the woods yet.
Pt vaccinated with DTP/OPV developed swelling at sight; area feels warm & tender. Treatment warm compresses return to office in 5 days.
Stiff and sore neck on the same side as the arm the vaccine was given. A grape sized bump about an inch superior to the collar bone on the same size as the vaccine given which does not hurt when touch. Fatigue for 3 days starting 3 days after the vaccine.
3 days post, pt notified clinic of nausea, muscle aches, burning sensation in her arm, and dizziness. Symptoms improved  Received 2nd dose on 4/14-now with dizziness, unsteady gait, tingling in all extremities
Facial tic (lasted less than 24 hrs) Scalp Rash ( red spots\dots on scalp that were initially pruritic) Extreme fatigue lasting less than 24 hrs.
About 2 hours after shot was given his leg got Red hot injection site aka leg. He was very cranky and crying and the next day his injection site was bruised with hard lumps, cranky baby.
After she recieved the shot, her arm was a little sore as usual after flu shot. Three days later, she woke up in severe pain, couldn't sleep, had to take Advil. This went on, she called me 10-14, still in severe pain. I told her to call her doctor, who told her to call them Monday (17th), got Celebrex, still having severe pain.
Pt recvd vax on 26NOV92 devel a postive blood culture for Haemophilus influenza, type c; pt was hospitalized; addtl into has been requested;
Patient felt faint around 5 min after vaccination. He was sweaty, pale, and dizzy. He was given monitored and was here with a friend who sat with him. Patient laid flat on the ground for 20-25min and began felling better. He left on his own shortly after that.
Rash-LUA, body aches, weakness, shakes, h/a; BP 130/80;
Case number PHEH2013US022230 is an initial spontaneous report received from a nurse on 21 OCT 2013, with the follow-up received on 18 NOV 2013. This report refers to a 3-year old months old male child who was inadvertently vaccinated initially with FLUVIRIN 2013/2014 (batch number: 13445P and expiry date: May 2015) at a dose of 0.5 ml intramuscularly on 18 OCT 2013 at 11:45 AM. It was reported that, he had not well visited to the clinic. No adverse event was reported following this administration error.  Follow-up received from nurse on 18 NOV 2013: Updated vaccination time and reporter comments.
Chills, fever, fatigue, heart palpitations, burning sensation from top of neck to tips of fingers, injection site rash, huge lump, itching, stiffness of arm, warm to touch at injection site, painful to touch at injection site. Still painful to touch and huge lump a week later.
This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got so sick), INFLUENZA (It was comparable to the worst flu she's ever had), MYALGIA (Horrible body pain/was as sick as she's ever been) and VOMITING (threw up so much) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 004M20A) for COVID-19 vaccination.     The patient's past medical history included Cancer. Concurrent medical conditions included Immunocompromised.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (Got so sick), INFLUENZA (It was comparable to the worst flu she's ever had), MYALGIA (Horrible body pain/was as sick as she's ever been) and VOMITING (threw up so much). At the time of the report, ILLNESS (Got so sick), INFLUENZA (It was comparable to the worst flu she's ever had), MYALGIA (Horrible body pain/was as sick as she's ever been) and VOMITING (threw up so much) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information IV was provided. Concomitant medication was not provided.   This case was linked to MOD-2021-343774 (Patient Link).
I had heart palpitations(PVC?s) from June 4th until July 15th. I?ve also had daily spotting and a little more than spitting at times from July 2nd until today August 1st. I have reported the heart palpitations and abnormal spotting to my dr.
I got my period and released a blood clot the size of a large date.   I typically release very small blood clots during my period but never the size of the what I released yesterday
fluzone hd qiv was given to a 62 year old patient in error with no reported adverse event; Initial information was received on 01-Nov-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 62 years old female patient who stated influenza quadrival a-b high dose hv vaccine [Fluzone HIGH-DOSE QUADRIVALENT] was given in error with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 01-Nov-2022, the patient received a suspect influenza quadrival a-b high dose hv vaccine at a dose of 0.7 ml once (lot UJ882AB, expiry date - 30-Jun-2023) via intramuscular route in the left deltoid for Immunization.  On an unknown date the patient stated a non-serious event of influenza quadrival a-b high dose hv vaccine was given in error with no reported adverse event (product use issue) (unknown latency) following the administration of vaccine.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  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 the guidelines. 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.
Information has been received from a physician concerning a 20 week old male with no allergies and diarrhoea and a history of reflux who on 26-SEP-2008 was vaccinated with a dose of ROTATEQ.  Concomitant therapy included REGLAN and PREVACID.  The patient had a stool sample positive for rotavirus and diarrhea after administration of ROTATEQ.  The patient received the ROTATEQ on 26-SEP-2008, but had diarrhea since 16-SEP-2008.  the patient was examined on 29-SEP-2008 and was found to have a positive stool sample for rotavirus.  The patient was hospitalized for observation and diarrhea.  The patient was released from the hospital on 04-OCT-2008 and reported as recovered.  A product quality complaint was not involved.  Additional information has been requested.
Initial and follow up information has been received from a physicians assistant through the Merck pregnancy registry concerning herself, a 26 year old female with no known allergies and no pertinent medical history who on 07-JUN-2007 was vaccinated with GARDASIL (Lot # 0212U) and discovered she was pregnant on 28-JUL-2007 (LMP 08-JUL-2007). Concomitant therapy included a prenatal vitamin. The patient sought medical attention (office visit). No labs or diagnostic studies were performed. On 02-OCT-2007, the patient reported she was twelve weeks pregnant, felt fine and had no adverse symptoms. On 05-DEC-2007 the patient underwent a routine ultrasound indicated for the pregnancy and the result was negative. The patient reported that on 10-APR-2008 she underwent a cesarean section due to delayed cervical dilation during labor. She delivered a normal male infant weighing: 6lbs 13ozs; length: 19". The patient reported that both mother and baby were doing fine. Upon internal review, the patient's cesarean section due to delayed cervical dilation was considered to be an other important medical event. Additional information is not expected.
After receiving vaccines listed below, 15 minutes after, Patient had syncopal episode, hit back of head on wall and had seizure activity.
Near-Syncope Episode with marked hypotension and ashen skin pallor. The patient received 0.3 mg epinephrine IM with full recovery.
Body aches; Fever; Dizziness; This is a spontaneous report from a contactable consumer. A 15-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and Expiration Date: not reported), intramuscularly administered in right arm on 05Jun2021 at 11:15 (at the age of 15 years old) as dose 2, single for COVID-19 immunisation. No medical history was reported. The patient did not have any allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162B2 (Lot Number: unknown), intramuscularly administered in the right arm on 15May2021 at 11:15 (at the age of 15-years-old) as dose 1, single dose for COVID-19 immunisation. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the vaccination and did not receive any other medications within 2 weeks prior to the vaccination. On 06Jun2021 at 00:00, about 18 hours after vaccination (as reported, possible discrepant), the patient experienced body aches, fever and dizziness. The events did not result in doctor or other healthcare professional office or clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of events, body aches, fever and dizziness which included treatment with paracetamol (TYLENOL) and ibuprofen (ADVIL). Outcome of all events was recovering.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Information has been received from a pharmacist, with no medical history of allergies, 43 year old female, who on 11-NOV-2008 was intramuscularly vaccinated with dose 1 of RECOMBIVAX HB.  Concomitant therapy included multivitamin.  On 12-NOV-2008 the patient experienced itchy all over her body.  She also had redness and hives.  She treated herself with BENADRYL at night but has not had improvement.  At the time of reporting she did not recover.  The pharmacist tried to contact her physician for medical attention but did not reach the physician.  Follow-up information has been received from a 43 year old asian pharmacist with no known allergies or pertinent medical history who on 11-NOV-2008 was vaccinated IM with a first dose of RECOMBIVAX HB at 15:00.  There was no illness at the time of vaccination.  Subsequently, on 12-NOV-2008 in the afternoon the patient experienced redness, hives and itchy all over her body.  Medical attention was sought, the patient had a doctor's visit.  There were no lab studies performed.  At the time of the report, it was noted that the patient recovered ten days later (21-NOV-2008).  Additional information is not expected.
I began having mild, localized left axilla pain and anterior shoulder joint pain at 24 hours post injection.   Over the next 24 hours (ie 48 hours post injection) the symptoms progressed to severe sharp, stabbing pain radiating to the left lateral neck along the jaw line, left anterior shoulder, left chest wall and along the left ribcage approximately T2/3 down to T9/10.  Also experienced gnawing-type stomach pain with some nausea at this time.  At the height of symptoms (approx 36 hours post injection), pain level was 9/10 and described as knifelike, sharp, and stabbing.  It was exacerbated by movement, particularly cough, sneeze, and hiccup.  Relieving factors included heat to the ice, but mild relief.  Pain levels began to diminish between hours 48 and 72 post-injection. By 72 hours post injection the jaw and left neck pain had resolved.  The left anterior shoulder/axilla and chest wall pain persisted, but severity had reduced from 9/10 to 4-5/10.  At 96 hours post injection severity had diminished to 2/10 with pain only at the left chest wall approximately T4/5 down to T9/10.  I am now 3.5 days out from injection and have pain level of 1/10 to the left chest wall with hiccup, sneeze, cough, and deep breath.
Started with itchy throat and cough, followed by full sinus congestion (could not breathe through nose at all, swollen throat (had a hard time breathing), dizziness, muscle cramps on right leg, and a general feeling of not being well.  Took 15 ml of Nyquil to try to relieve some of the symptoms, stayed awake the whole night and took seeps of icy cold water, used ice pack on the neck.  Considered calling emergency, but did not do so, as the symptoms started improving toward the morning.  Continued having light flulike symptoms on Saturday and Sunday, still feeling a little bit weak and tired but other than that, everything seems to be back to normal.
Patient describes soreness, pain and muscle aches, fever and fatigue. Also reports there a bump at the injection site and it causing itchiness.
PATIENT SAID SHE WOKE UP WITH BODY ACHES IN LEGS, BACK, NECK, AND RIBS ACCOMPANIED BY A FEVER.
4/22/09-Pt c/o "scratchy throat"-No other sx. 4/23/09 Pt c/o sore throat. States "lost voice." 4/25/09-3 AM pt. states woke up and "could not swallow." No diff breathing pr other sx. Pt went to ER for tx.
Sharp under arm pain (left side) Tight Chest Pain, Minor Numbness of the right Arm.
14 hours after vaccine: nausea, screaming headache, arm so sore I couldn't lift it, fatigued  INSOMNIA. Starting the second night after the vaccine: insomnia. Feeling "wired." Could only sleep for about 3-4 hours. The insomnia reoccurred every other night for the next 12 nights. I've never ever experienced insomnia before this, in my 52 years.   I'm not sure if I need to fill out another form--but after my second Pfizer dose (lot #EW0171), I experienced insomnia again the third night after the vaccine--and two or three other times over the next three weeks.
Within minutes of the DTAP, pt had reaction, wheezing, sob, tickling in the throat, appeared grayish in mouth, 2 tsp BENADRYL, alb nebs X 2, SOLUMEDROL 36 mg X 1. O2 92% & after O2 99% Pt. given epi-pen Jr X 1 in office for anaphylactic.
Received expired booster vaccine >12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired booster vaccine >12 hours post puncture) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Dec-2021 at 3:18 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Dec-2021 at 3:18 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired booster vaccine >12 hours post puncture). On 16-Dec-2021 at 3:18 PM, EXPIRED PRODUCT ADMINISTERED (Received expired booster vaccine >12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  It was reported that administered an expired Moderna COVID-19 booster vaccine  to a patient. The patient's first 2 doses were Moderna brand COVID-19 vaccine as well. On 14 Dec 2021, the vial was initially stored in the refrigerator. First punctured was done on 15 Dec 2021 at 10:48 AM.  Treatment information was not reported.
Information has been received from a healthcare worker referring to a 6 month old patient of unknown gender. The patient's concurrent and historical conditions were not reported. On 23-DEC-2014, the patient was vaccinated with the first dose of PEDVAXHIB at the age of 2 months. On 03-MAR-2015, the patient was vaccinated with the second dose of PEDVAXHIB at the age of 4 months. On 07-MAY-2015, the patient was vaccinated with the third dose of PEDVAXHIB at the age of 6 months (Inappropriate schedule of vaccine administered). Dose, route, lot # and expiration date for all were unknown. No adverse effects were reported. Additional information has been requested.
Note: I cannot go back to see what  Item 4 was without losing all my information. I am answering as if it pertains to my 3rd dose of the Pfizer vaccine, received on 10/25/21. Beginning 10/29/21, I began experiencing very high Blood pressure readings and extreme tachycardia.  20+ incidents of unambiguous tachycardia (12, 113, 114, 112, etc.) were taken throughout November, all taken at rest and double checked against a professional metronome.(I understand that BP readings vary wildly with consumer BP meters, but heart rate is accurate and was cross-checked against a metronome).  Tachycardia subsided with significant increases to existing BP meds, but BP remained high until a new doctor evaluated me and immediately insisted on additional meds. My former PCP was contemptuosly dismissive of even NIH reports noting the fact that Myocarditis and elevated BP can be a side effect of the vaccine. To her, reporting a side effect was equivalent to vaccine denial.  Again, I have had THREE Pfizer shots.
Patient complained of nausea and feeling hot.  Patient was given Benadryl 50mg and then symptoms resolved.
ONSET OF TINGLING OF 2ND-5TH ENTIRE DIGITS OF THE LEFT HAND AT 8PM NIGHT OF IMMUNIZATION. THEN RADIATION OF TINGLING AND NUMBNESS TO DORSUM OF HAND, WRIST, PROXIMAL EXTENSOR FOREARM WITH SENSE OF MOTOR WEAKNESS OF HAND. NO LOCAL CHANGES AT VACCINATION SITE. NO FEVER, SYSTEMIC COMPLAINTS OR OTHER FOCAL NEUROLOGICAL SYMPTOMS. SEEN AT MY OFFICE TODAY AT 10:30AM. AFEBRILE, BP 128/88 TEMP 95.7. LOOKS WELL. NO SIGNS CHANGES. NO SOFT TISSUE CHANGES AT THE INJECTION SITE-LEFT POSTEROLATERAL PROXIMAL ARM. NO ADENOPATHY. JAMAR TESTING-RIGHT HAND (DOMINANT) 54/58/52; LEFT 32/36/34. MOTOR TESTING 5/5 BILATERALLY ALL ETREMITIES, LT TOUCH TESTING OVER LEFT DORSAL FINGERS AND DORSAL HAND TRIGGERS TINGLING. OTHERWISE INTACT. DTRS 2+=.
Fever the night of immunizations went up to 105. Body achy. was up most of night. Fever off and on. 8-10-07 started to feel better. 8-11-07 doing well.
Patient head was bobbing and the nurse thought it might have been a seizure. Onsite EMS was called vitals BP 149/88   HR 56  97% O2. He felt better and was released home.
I gave the patient their moderna vaccine today (5/25/23). About 20 minutes after they left, I found out that the beyond use date for the vaccine was yesterday (5/24/23). The vaccine is not expired. It has an expiration date of 6/10/23. So it was past the BUD (by one day), but not the expiration date.
Patient reports that she has had soreness in her left arm where the vaccination was given. Patient says she has been having pain in her arm at the injection site since she received the vaccination. Patient says that her arm hurts (sharp pain) when lifting her arm up over her head. Patient has not yet gone to the Doctors office to have her condition diagnosed.
ANKLE SWELLING, DISCOMFORT AND REDNESS/CELLULITIS; This spontaneous report received from a consumer concerned a 61 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included quadriplegia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805031) dose was not reported, administered at left arm on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-MAR-2021, the patient had swelling with in his right ankle with significant discomfort. On 18-MAR-2021, the had redness in his ankle. On 21-MAR-2021, the patient went to emergency room where the treating physician mentioned he had cellulitis. On MAR-2021, the patient received treatment medications clindamycin hydrochloride (Cleocin 300mg IV) and would be on unspecified antibiotics for 7 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from ankle swelling, discomfort and redness/cellulitis. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210342988-COVID-19 VACCINE AD26.COV2.S-Cellulitis. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not provided. On 06-DEC-2017, the patient was vaccinated with double dose (1.0 ml) of M-M-R II, subcutaneously (lot number and expiration date were not provided) for prophylaxis. Other suspect therapies included sterile diluent (STERILE DILUENT) used to reconstitute the vaccine. The patient experienced no adverse events. The outcome of incorrect dose administered was unknown.
1/2 hr after vaccination, patient went to ER at hospital for swollen tongue and difficulty in breathing. Admitted for IV BENADRYL and SOLUMEDROL.
Post vax the patient experienced exanthem, generalized occipital lymphadenopathy and had low-grade temperature 48 hours after the vaccination.