chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This prospective pregnancy report was received from a nurse practitioner via a company representative, concerning a pregnant female patient of an unknown age. The patient's medical history included chickenpox. Her concurrent conditions, concomitant medications, drug reactions or allergies were not provided. On an unspecified date, while the patient was pregnant (unspecified duration), she was exposed to her vaccinated son with VARIVAX (lot #, expiration date, strength, dose, frequency and anatomical location of the injection were not reported) (Exposure to vaccinated person). The patient last menstrual period (LMP), pregnancy due date, trimester of exposure and pregnancy outcome were not reported. The reporter stated that there was a concern for the pregnant patient and the unborn fetus, but the mother's obstetrician and gynecologists (ob-gyn) provider stated that both the mother and the unborn fetus should be fine, since the mother has already had the chickenpox before (unspecified date). No other information was provided on this matter. No product quality complain (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1703USA006978: US-009507513-1703USA009915:
the next day vaccine soreness and joint pains in knees and shoulders like the flu and progressed, some days I cant go to work, when I am aching I get dizziness with with. Fatigued and tired,= and wears me out. I was already having it from the 1st dose and now it increased and got worst. Doctor several times and urgent care several times no ER, have vertigo.
Pt reports big red spot/hive to left arm going down to elbow, itchy and sore to touch.
seizure & inc temp @ 12MN (t103); pt taken to ER; spinal tap, blood work, phenobarb given; home on 22AMR92 on no meds;
Patient began experiencing symptoms of a itchy, red swollen area around her left elbow on Thursday 3/11. The area on 3/13 was still itchy, swollen and red, along with three pus-like spots on the swollen area. She stated that the area had not grown in size since Thursday but had not decreased either.  Patient was unsure if related to the vaccine or if she received an unknown bite(s) (insect, etc). The skin area was not warm to the touch and no fever reported.
I developed a red, itchy rash at and below the vaccine site after 8 days on my upper right arm.  It became itchier after 9 days, it disappeared after 10 and 11 days, and it reappeared after 12 days, spreading to the left upper arm and both thighs.
Pt complained of tingling tongue about f15 min after Pfizer vaccine.  She has h/o anaphylaxis, but this does not feel the same. Denies SOB, CP, or any other symptoms.  Decided to administer 50mg Benadryl p.o. out of an abundance of caution.  Pt improved & went home.  Knows to call PCP for worsening symptoms
I verified that the time interval was correct for receiving Dtap and polio. I looked at the IZ containing HIB and the one containing HepB and I knew that the child did not need either of those. Then the next combination selection was KINRIX which had everything that child needed. There was no indication on the box that it was a specific age range. I looked at the card on the bin and it said pediatric. I was rushed because I had other clients waiting in the lobby. This client was suppose to be here the day before and instead showed up on this date thinking this was the time of the appointment. I wanted the child to get their IZ's so I was squeezing them in. I did not look at the insert and there was not quick guide on the fridge.
Oval 2x4", swollen, hard, red, lump @ injection site itching was bothersome, used BENADRYL cream to treat seems to be getting smaller, less itching.
Pain in left arm at point of flu vaccine and shoulder.  Reduced range of motion in shoulder/arm. On 2/17/15, received diagnosis of Adhesive Capsulitis or Frozen Shoulder from Orthopedic Specialist.  On 2/19/15, started Physical Therapy and OTC Pain Meds (Acetaminophen and Ibuprofen) as prescribed.
Patient reported eyes are sensitive to light, rt arm very sore, reddened and warm. Temperature 103.1. In no acute distress. RN Supervisor notified Dr., Director of International Center and district ARNP. Decision was made to transport to Emergency Department.
The patient was given the Pfizer Monovalent vaccine instead of the Pfizer Bivalent vaccine.  No adverse side effects were noted.
A week after receiving 2nd vaccine dose, I broke out in hives over my extremities that lasted the 1st episode for 11 days, along with severe headaches. At onset my lips will start burning, skin begins to tingle along with the headache and the hives start forming. These episodes have been happening monthly with the same symptoms but the duration of the time varies between 4 to 8 days typically. I have had to take prednisone, inhalers, and steroids to calm the effects of the hives which also has effected my breathing. I have had to take off of work because of these hives & accompanied headaches.
limited scleroderma and it made it worse because the skin hardens and she can hardly make a fist; limited scleroderma and it made it worse because the skin hardens and she can hardly make a fist; got gangrene on her finger, it was dark purple but not black which gangrene is the next step; then getting the booster it triggered her Reynaud's' phenomenon and made it worse; Each time the vaccines effected her memory; Each time the vaccines effected her memory; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. Medical history included Raynaud's phenomenon and scleroderma from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously had BNT162B2 dose 1 and dose 2 on unspecified dates for COVID-19 immunisation and experienced COVID-19 and it effected her memory. The patient had her booster it triggered her Reynaud's phenomenon and made it worse. The patient also has limited scleroderma and it made it worse because the skin hardens and she can hardly make a fist. The patient almost got gangrene on her finger, it was dark purple but not black which gangrene is the next step. The patient's fingers were painful and hurt to the touch because her finger tips are also very cold because of the Raynaud's. The caller is having to wear gloves 24/7 because of this. The patient's finger turned purple almost black, gangrenous, had Raynaud's and limited scleroderma worsened. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
fever 104.8 R; no redness around inj sites; petechial rash;
pericarditis, exacerbate asthma to moderate copd, metal taste in mouth immediately, chest pressure, stabbing and burning pain
A third dose of Pfizer Biontech administered to patient on 2-19-21.  First dose was 1-8-21, second dose 1-29-21,  third dose 2-19-21.
Patient was given 2 doses of the Fluarix vaccine (influenza vaccine; CPT 90686). Pt was being seen by his PCP, immediately before being seen by pharmacist. Dr. ordered Fluarix and the vaccine was given and documented by MA. The current workflow for administering influenza vaccines is to dispense the vaccine from the stand alone refrigerator and forgo inputting information into the AccuVax machine. The AccuVax removes the alert for an ordered vaccine once the vaccine is removed from the AccuVax or at midnight of that day, whichever occurs first. During pt?s pharmacy appointment, pharmacist ordered pt?s second dose of his Energix-B vaccine (Hepatitis B vaccine; CPT 90746) series. When MA, went to dispense the Energix-B vaccine from the AccuVax machine, an alert showed stating an influenza vaccine was also ordered for the pt. MA acknowledged the alert and also dispensed an influenza vaccine from the vaccine refrigerator. MA then administered both the Fluarix and Energix-B vaccine to the patient then informed another MA, and pharmacist. Patient was informed that he received a second dose of the influenza vaccine by accident and his dose of the Energix-B vaccine. Per website pt unlikely to experience and side effects and the vaccine given is counted as a valid vaccine.
Polymyalgia rheumatica; had some reaction/some stuff for one day; achy; This spontaneous case was reported by a consumer and describes the occurrence of POLYMYALGIA RHEUMATICA (Polymyalgia rheumatica) in a 90-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received fifth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced POLYMYALGIA RHEUMATICA (Polymyalgia rheumatica) (seriousness criterion medically significant), IMMUNISATION REACTION (had some reaction/some stuff for one day) and PAIN (achy). The patient was treated with PREDNISONE for Polymyalgia rheumatica, at an unspecified dose and frequency. At the time of the report, POLYMYALGIA RHEUMATICA (Polymyalgia rheumatica) outcome was unknown and IMMUNISATION REACTION (had some reaction/some stuff for one day) and PAIN (achy) had resolved.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Patient was taking Prednisone from 6-10 months. Patient took all Moderna vaccin  Company Comment This spontaneous case concerns  a 90-years-old female patient with no medical history reported who experienced the seriousness criteria medically significant unexpected event of polymyalgia rheumatica; the unexpected events of pain and immunization reaction unknown days after 5th. dose of SPIKEVAX NOS vaccine. The age could be a contributor for the events. The benefit-risk relationship of SPIKEVAX NOS vaccine is not affected by this report. es and only had some reaction - achy and some stuff for one day.
Local reaction to LT posterior upper arm; Redness, swelling & warmth. Moderate relief noted with Motrin and ice pack.
10/30/09 cough, runny nose 10/31/09 fever 3:00-4:00pm 11/1/09 "spots" on body in pm 11/2/09 Dr. reports "hives on abdomen, face, L and R arm ic fever 99.5 degrees and cough.  11/3/09 Hives improving - temp 97.6 degrees.
Headache, chills, shaking by 8PM vomiting and after the vomiting stopped.  A temperature of 101.4. Sick throughout the night.  The next morning, I felt weak and had a large hard circle around where the shot had been administered.  The symptoms lasted approximately 24 hours.  I took Tylenol but didn't feel like eating and took a long nap. The following day I felt better though a little weak.
No Additional AE; the patient was given PROQUAD instead of MMR II.; The PROQUAD also suffered from a non supported temperature excursion.; This spontaneous report has been received from a pharmacist referring to a patient of unknown age or gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies were not reported.  On 17-MAY-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (albumin status recombinant human albumin (rHA)) (PROQUAD)  injection, lot #W029552, expiration date: 14-MAR-2024, administered for prophylaxis (strength, dose, and route of administration were not provided), instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection (strength, dose, lot #, expiry date, and route of administration were not provided) (wrong product administered). The measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) also suffered from a non supported temperature excursion (product storage error). It was reported that measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was underwent temperature excursions at 8 degree Celsius (C) for 1320 hours. There were no previous temperature excursions. No additional AE or PQC was reported.
2 days after vaccine administration +fever 101, also had new lower back pain radiating down legs bilaterally, then new Rt lower back pain that radiates down scrotum and thigh/calf; also recent 2 days has had urinary hesitancy and increased urinary frequency, and mild fatigue
Patient received vaccines that were previously exposed to temperatures below 32 degrees F, no adverse event; Initial information received on 12-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA192700, 2019SA193109, 2019SA193112, 2019SA193111, 2019SA193113, 2019SA193107, 2019SA193106, 2019SA193105, 2019SA192698 and 2019SA192699. (Same reporter).  This case involves a 12 months old male patient who received vaccine HIB (PRP/T) VACCINE [ACT-HIB] (lot UI969AAB, expiry date- 04-Apr-2020) via intramuscular route in unknown administration site, which was previously exposed to temperatures below 32 degrees F.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No other vaccines were given.  It was an actual medication error due to incorrect product storage.  It was unknown whether the patient had any adverse 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
pt devel lump, erythema, & tenderness @ inject site p/recvd DT/MMR/OPV;
Felt leg pain, heavy legs, burning sensation.  The symptoms were more acute  for the first week, still having some symptoms but a little lighter.
PATIENT RECIEVED THERE THIRD DOSE OF PFIZER. AFTER RECEIVING THE VACCINE, I WAS BROUGHT TO ATTENTION, THA THE PATIENT WAS NOT DOING WELL.  UPON CHECKING THE PATIENT, THE MOTHER TOLD ME THAT HER ARM WAS HURTING AND FELT A SUDDEN RUSH THROUGH HER BODY.  SHE WAS HAVING DIFFICULTY BREATHING AND PASSED OUT MOMENTARILY.  SHE WAS STILL BREATHING AND HAD A PULSE. I STAYED WITH THE PATIENT UNTIL THE PARAMEDICS ARRIVED. THEY DETERMINED THAT THERE WAS NO ALLERGIC REACTION AND IT WAS JUST DUE TO ANXIETY WHICH LED TO SYNCOPE.  SHE WAS NOT TAKEN TO THE HOSPITAL AND WAS ALLOWED TO RETURN HOME.+
Headache, Myalgia, Fever, NauseaVomiting, Hand erythema and swelling Narrative:
Patient fainted and felt dizzy for ~15 minutes. no other symptoms.  s/sx lasted ~15-20 minutes. pt refused medical treatment
Patient suffered vertigo, dysequilibrium leading to fall risk, relapse of anxiety disorder, relapse of formerly-improved post-COVID sx (dysgeusia, nausea), and suffers from migratory arthralgias.
The day after he received his shots his arm swelled up and hurt a lot. It was warm too. He used BENADRYL for a few days and that helped the swelling. He had a bruise for a couple days but now he is fine.
Rec'd 12 yr. IMM. 3/23/17 at office. (RT) arm with redness, edema and warmth beginning that PM. Also with smaller area redness only to (LT) arm. Tx with BENADRYL and Ibuprofen with 6 degree area of redness outlined; to return if S/S worsen.
This case was reported by a nurse via sales rep and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever and adverse event. On an unknown date, the outcome of the fever and adverse event were unknown. It was unknown if the reporter considered the fever and adverse event to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. SHINGRIX dose number was unknown in series. Lot number as not given in reporter's practice. Vaccination date and duration was not provided. The customer heard about one of her physician's wife experienced low fever and systemic side effects. The physician's wife not hospitalized, side effects were resolved. The customer's knowledge was secondhand. The reporter agree to follow up. This case was linked with cases US2017GSK170696 and US2018GSK153190, reported by the same reporter.
Patient became aware of firm, oval shaped lump in (R) arm subq fat. area upon awakening. The area increase 2 x's in size with increased warmth and tenderness. By mid afternoon sought care at walk-in clinic, and was referred to hospital. No tx.
Information was received from a 81 years old female consumer stated that she received ZOSTAVAX subcutaneously (dosage unknown) for the treatment as part of a clinical study in 2005. She stated that she did get the shingles on her right side in the lower back spine, and buttocks region on 22-NOV-2011. She was treated with VALTREX. Unspecific medical attention was sought. At the time of the report, the outcome of AE was not reported. Action taken with the study therapy due to the event was not applicable. The relationship between study therapy and AE was not reported. Additional information has been requested.
Systemic: slight numbing in left arm-Mild, Systemic: Nausea-Mild
Patient reports swollen, red, painful, and warm arm. Pt had been icing on and off. Urgent care believes arm may be infected. They gave patient a course of antibiotics.
patient still get sick; Initial information received on 06-Dec-2020 regarding an unsolicited valid non-serious case from a consumer or non-health care professional (Patient) via social media.  This case involves patient (age unspecified) who experienced patient still get sick (illness), while patient received vaccine INFLUENZA VACCINE [Flu shot].  Medical history, medical treatment, vaccination, concomitant medication 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 and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious patient still get sick (illness) unknown latency following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.    It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for event.  There will be no information available on the batch number for this case.
VAXNEUVANCE syringe breaking in nurses hand and cutting her finger; VAXNEUVANCE syringe breaking in nurses hand and cutting her finger; VAXNEUVANCE syringe breaking in nurses hand and cutting her finger; two VAXNEUVANCE syringes were dropped and the necks of the syringe broke in half; This spontaneous report was received from a registered nurse via a company employee and referred to a female patient of unknown age. The patient's medical history, concurrent conditions, concomitant therapies and drug reaction/allergies were unknown by reporter.   On an unknown date, two pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection (indication: prophylaxis; strength, dose, lot #, expiry date and route of administration were not provided) syringes were dropped and the necks of the syringe broke in half (syringe issue). Nurse was concerned about the quality of the glass pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) syringes since this was the second time this happened. Nurse stated the last time this happened, the pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) syringe broke in a nurse's hand and cut her finger (skin laceration, occupational exposure to product, injury associated with device). It was unknown whether the patient sought medical attention or any treatment was given. Information about lab diagnostics/studies was unknown by the reporter. The outcome of all events was unknown. The causal relationship between all events and pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) was not provided.
Patient walked into clinic requesting flu vaccine. Pt denied allergy to eggs, stated she has received flu vaccine in the past. Received High-dose flu vaccine for ages 65 and over. Patient states experienced rash on lower extremities with itching later that evening. States used Epsom salt bath to alleviate symptoms. Stated rash had almost completely disappeared by day 4 following the vaccine adm.
Difuse varicellaform rash on chest, back, abdomen, buttocks, upper thighs. Treated with diflorasone diacetate ointment for itching.
Pfizer 6/28/21, 7/22/21. Positive on 6/12/22
Information has been received from an office manager, concerning patient of unknown age and gender. The patient's medical history, concurrent conditions, previously drug reactions, allergies and concomitant medications were not provided. On 25-FEB-2019, the patient was vaccinated with VARIVAX injection, 0.5 ml/once intramuscularly, lot number R022115 with expiration date 02-AUG-2020 (strength and anatomical location were not reported) which was reconstituted with sterile diluent (manufacturer unknown) intramuscularly lot number M041089 with expiration date 10-JUN-2019 (formulation, strength, dose, frequency, indication, lot number and expiration date were not reported). No adverse effects were reported.
Information has been received from a registered nurse concerning an approximately 20 year old male who as a child was vaccinated with measles virus vaccine live. Subsequently the pt developed high fevers and seizures. The nurse reported that "the pt needed to receive MMR II vaccine for INS status." Upon internal review seizures was considered an other important medical event (OMIC). No additional info is expected.
2 weeks ago, she started feeling achy; muscle aches; knees are sore; if rub arm at injection site it is still a little sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (2 weeks ago, she started feeling achy), MYALGIA (muscle aches), ARTHRALGIA (knees are sore) and VACCINATION SITE PAIN (if rub arm at injection site it is still a little sore) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (2 weeks ago, she started feeling achy), MYALGIA (muscle aches), ARTHRALGIA (knees are sore) and VACCINATION SITE PAIN (if rub arm at injection site it is still a little sore). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (2 weeks ago, she started feeling achy), MYALGIA (muscle aches), ARTHRALGIA (knees are sore) and VACCINATION SITE PAIN (if rub arm at injection site it is still a little sore) outcome was unknown.            Treatment included heated up rice bag. Concomitant medication information was not reported. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) is considered as not applicable.