chrisvoncsefalvay/vaers-outcomes huggingface dataset:
forgot to put the powder in the Pentacel, no ae; patient was given only the DTaP-IPV (liquid) portion and did not give the powder part of ActHIB, No AE; Initial information received on 25-Feb-2021 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a two-year-old patient who was forgot to put the powder in the pentacel,(product dispensing error) and patient was given only the dtap-ipv (liquid) portion and did not give the powder part of acthib (product administered to patient of inappropriate age) after receiving DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  The patient developed a non-serious forgot to put the powder in the pentacel,(product dispensing error) and patient was given only the dtap-ipv (liquid) portion and did not give the powder part of acthib (product administered to patient of inappropriate age following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  (This was an actual medication error due to inappropriate reconstitution technique (PT: product preparation issue) (latency was same day).  No laboratory data reported.  At the time of reporting, no adverse event was reported to the patient.  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.
EPSTEIN BARR INFECTION; HEADACHE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. 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, route of admin not reported, batch number: unknown) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch and lot numbers. No concomitant medications were reported.  On APR-2021, Laboratory data included: Blood test (NR: not provided) Elevated epstein barr numbers, Covid-19 antibodies. On 07-APR-2021, the subject experienced epstein barr infection. On 07-APR-2021, the subject experienced headache. On 10-APR-2021, Laboratory data included: Body temperature (NR: not provided) 37.2 to 38.3 degree celsius or 99 and 101 degrees. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 08-APR-2021, and had not recovered from epstein barr infection. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Narrative:  PATIENT PASSED AWAY DUE TO COVID-19. PT WAS HOSPTILIZED AND FULLY VACCINATED AT THE TIME OF HIS DEATH.
This case was reported by a physician via sales representative and described the occurrence of flush all over in a 4-month-old subject of unspecified gender who was vaccinated with PEDIARIX, (GlaxoSmithKline), HIB, (non-gsk) ROTATEQ and PREVNAR.  On an unspecified date, the subject received 2nd dose of PEDIARIX (.5 ml, unknown), unspecified dose of HIB (unknown), unspecified dose of ROTATEQ (unknown), unspecified dose of PREVNAR (unknown).  At an unspecified time after vaccination with HIB, PEDIARIX, PREVNAR and ROTATEQ, the subject experienced flush all over and skin turned red.  The physician reported a 4-month old subject experienced flushing all over and turned bright red after receiving his 2nd PEDIARIX.  At the time of reporting the outcome of the events were unspecified.  The physician considered the events were possibly related to vaccination with PEDIARIX, HIB, ROTATEQ and PREVNAR.
This is a 89y.o. female with past medical history of CVA in 2018 (right-sided deficits), TAVR placement 2018, cardiac catheter in 2018, dual-lead defibrillator in place, type 2 diabetes, hypothyroidism. Presenting to the emergency department after a fall.   Upon speaking with son on the phone. Son states that for the past week his dad is in complaining that he felt off. He states that Wednesday when he talked to him on the phone his dad said he wasn't feeling that well. Thursday for Thanksgiving his mom and dad decided to stay home. Friday he took him over some food to his parents house, to see how they were feeling. Saturday he called his parents house phone in the morning and he did not answer. He.they might be out for breakfast, he states that his parents go out to breakfast 3 times a week. He said since they weren't answering towards the evening hours he decided to drive over their house, he lives almost an hour away. When he arrived he found both his mom and dad lying on the floor away from each other.    His dad states that he fell down after using the bathroom in the middle of the night, due to him tripping over his own legs. He denied any loss of consciousness. His mother who chronically uses a walker/wheelchair tried to assist his father off the ground. She then fell on the ground as well and was unable to get up. She was on the ground for approximately 13 hours.    Patient states that over the course of the week she has been feeling more fatigued. She states prior to this she has never had a fall. But this week that this week she fell 3 times, once Thursday, once Friday and one Saturday. She denies loss of consciousness with falls, she states that her right leg was feeling even weaker than normal. She only endorses right ankle pain. She ambulates the house with a walker or wheelchair. Patient denies shortness of breath, cough, chest discomfort. Patient was vaccinated 2x for COVID, awaiting getting booster. No flu shot this year   ED course:   Vitals: BP 152/86, heart rate 91, respiratory rate 18, temp 98.3F, SPO2 98% on room air   Labs: GFR 58, AST 66, prealbumin 10, CK 898, LDH 613, d-dimer 1900   Imaging/tests: Ankle x-ray showing soft tissue swelling without acute osseous abnormality, moderate degenerative changes, chest x-ray showing groundglass opacities in both lungs, right hip showing no acute fracture or dislocation with mild to moderate bilateral hip osteoarthritis, right knee showing soft tissue swelling and trace knee joint effusion without soft tissue gas, intact appearing total right knee arthroplasty, tibia and fibula x-ray showing soft tissue swelling without soft tissue gas or osseous abnormality with intact told her a knee arthroplasty
Vaccine was past the DO NOT USE After Time of 5/12/2022 at 11:00PM
significant arm pain after COVID vaccine; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 36 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "significant arm pain after COVID vaccine". This AE was spontaneously reported to me by a friend after they received the COVID-19 injection.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
PATIENT DESCRIBED A BASEBALL SIZE BUMP ON THE INNER PART OF HER UPPER ARM.
Two weeks after the injection, on Friday, February 12th,  my arm was itchy and had a couple dots or a line of redness.  In the morning, a rectangular area near the injection site was bright red, inflamed, warm, and itchy.  The upper arm felt sore. The area was about 2 inches by 2 inches.  The center of this area was mostly clear. I used a Benadryl cream to relieve the itching. It looked the same on Sunday, and I used the Benadryl cream for the itching again. On Monday morning, the redness of the area had decreased. On Tuesday morning (today), there is a small additional area of redness below the original site, but the original site is barely visible.  It is no longer itchy or warm.
Information has been received from a Nurse Practitioner concerning a female patient who received three doses of GARDASIL and now has a positive Papanicolau (PAP) test.  It was reported that the patient was HPV positive and it was high risk.  The patient sought unspecified medical attention.  Additional information has been requested.
received vaccine at 8 AM, reaction not noted until 3 PM. Complained of hot, flush, tired, anxious, heart racing, EMS came, evaluated and pt refused to go to hospital.
This spontaneous case was initially received on 29-Sep-2015. The case report was received from a Health Professional and concerns a female patient. The patient received AFLURIA not on unknown dates, Batch no: not provided, Route of administration: Unknown, Dose: no information provided. Unspecified vaccine (possibly Tdap), Indication: not provided. On an unknown date, after starting treatment with AFLURIA the patient experienced Systemic hives. Reporter's assessment: Not reported.
I received the Moderna bivalent vaccine at about 1:15 pm on Saturday, October 15, 2022.   There was a strong stinging sensation with the vaccine was administered which continued for just a few minutes.  Other than soreness around the injection site, there was no issue until about 3 am on Sunday, October 16, 2022 when I was experiencing fever and chills.  Later on the 16th, I had a mild sore throat.  By the evening of the 16th, I had also developed a cough.  On Monday, October 17, there was lung congestion and a productive cough (yellowish sputum).  That continued, along with fever and aches, on Monday October 17 and Tuesday, October 18.  I also had very limited energy.  By now, Wednesday, October 19 at 1:30 pm, the coughing is improved, but my throat is a bit raw and occasionally feels constricted.  However, I have considerable sneezing and rhinitis.   It seems like I have a cold or flu which happened to start right after my vaccination.  However, my wife who lives with me and my brother with whom I have spent several hours each day have not contracted this cold or flu.  This makes me suspect that my symptoms are the result of the vaccine and not a coincidental separate event.
Patient called Monday morning said swelling began at site of flu vaccine and stated she went to emergency room.
pt states he developed a rash on his back about 8 days after he got the Covid vax. Pt went to Urgent Care on 3/13/2021. Pt was prescribed methylprednisolone 4mg.  The has since spread to his arms and legs. He has taking Benadryl, used cortisone and other medicine to help with the itching. Pt states the itching and the rash seems to be getting better. Pt will contact the UC physician to see if he can pinpoint why he has this rash and also schedule an appt w/ Dermatologist.
Case number PHEH2014US024297, is an initial spontaneous report received from a nurse on 02 Dec 2014, with a follow up received from nurse on 21 Jan 2015. This report refers to a 50 years old male patient. Past medical history was not reported. Concomitant medications were none. The patient was vaccinated with FLUVIRIN (batch number: 14511P, expiry date: Mar 2015) intramuscularly into the right deltoid at a dose of 0.5 ml on 19 Nov 2014. The nurse reported that before vaccination the prefilled syringe (PFS) of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. The patient did not experience any adverse reaction due to the maladministration (incorrect storage of drug). Follow up received from nurse on 21 Jan 2015: updated site of vaccination and reporter comment.
Day 1: pain localized to left arm, sore, achey heavy arm, small quarter size red patch of injection site Day 2: pain increase down arm and up left side of neck Red patch increased in diameter  Day 3: pain increased over entire left arm, under arm, throughout left breast and neck, cheek, jaw behind ear. Throbbing, aching, and dull.  Red patch increased to size of entire palm, raised, hot and itching.
10 hours after   Injection  terrible headache, then chills, &  aching in my back and torso, fever of 99° (my normal temperature is 96.8 ).  A couple of hours later temperature went to 100°, several hours later temperature went to 101.3. All the while the headache and muscle ache continued. I took two regular aspirin after about 16 hours from injection , Took another two aspirin about 24 hours after injection. Symptoms lasted about 32 to 34 hours. Felt better but a little sluggish
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male patient who received SHINGRIX. On 17th May 2018, the patient received SHINGRIX. In May 2018, less than a week after receiving SHINGRIX, the patient experienced pain in arm, general body pain, chills and fever. On an unknown date, the outcome of the pain in arm, general body pain, chills and fever were unknown. It was unknown if the reporter considered the pain in arm, general body pain, chills and fever to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's wife. The age at vaccination was not reported. The patient received SHINGRIX injection at a pharmacy and complained of chills, fever, general achiness, and a sore arm. No other details were available for the patient. The reporter did not wish to provide the patient's demographics. She hung up the call when she got her answer despite of asking her if some questions might be asked. This case is linked to case US2018089389 (wife's case), reported by the same reporter.
Initially localized reaction: pain, swelling at injection site. Next day started diarrhea, very painful joints, severe pounding headache, nausea, vomiting, sweating, chills.
This spontaneous report as received from a register nurse refers to a 4 months infant, of unknown gender. Medical history and concurrent conditions were not reported. On 05-MAR-2014, the patient was vaccinated with dose 2 of ROTATEQ, lot #J007283; expiration date: 27-SEP-2014 (dose and strength were not reported. Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored ROTATEQ was administered to patient. No adverse effects reported. The nurse reported that vaccine dose received by patient was a vaccine improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Body aches and chills.  Chills persisted for approximately 26 hours.  Body aches continued for 36 hours.
This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 81-year-old female patient who received SHINGRIX. Concomitant products included Pneumonia vaccine. On 25th April 2018, the patient received the 1st dose of SHINGRIX .5 ml. In April 2018, less than a week after receiving SHINGRIX, the patent experienced general body pain, tiredness and fever. On an unknown date, the outcome of the general body pain, tiredness and fever were unchanged. The reporter considered the general body pain, tiredness and fever to be possibly related to SHINGRIX. Additional details were provided as follows: At 12:00 hours, the patient received SHINGRIX and Pneumonia vaccine at same time of different arms. The reporter did not have phone number of her physician to provide. All questions were asked but the reporter had provided limited information due to time constraint.
BEGAN SHIVERING CONSTANTLY UNTIL ASLEEP. WOKE UP ABOUT 8 HOURS LATER FEELING WEAK AND DIZZY. LEANING ON COUNTER PREPARING FOOD THEN SUDDENLY WOKE UP LYING ON FLOOR. RESTED IN CHAIR MOST OF DAY. PUSHED GATORADE FOR HYDRATION AND ATE LIGHTLY AND REGULARLY. FELT NORMAL BY 11;00 PM.
I started to feel really tired around 7:30pm and got a head ache so I went to bed early. I couldn't sleep well because I got the chills and a fever. I went to use the bathroom around 3am. All of a sudden I got really nauseous, the room spun, everything went black and I fainted in the middle of my bathroom. My wife woke up and helped me back to bed. The next day I was very weak and tired. The chills and fever faded the next afternoon.
Choking, gasping, stridor while infant was in car seat and mother was driving. Lasted a "few minutes" - self resolved with crying and return to baseline. No oral intake since vaccination. No known objects in car seat. Taken to urgent care center. Examination including chest x-ray without findings.
5 patients received a Moderna booster shot of 0.5ml not 0.25ml; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL OVERDOSE (5 patients received a Moderna booster shot of 0.5ml not 0.25ml) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE (5 patients received a Moderna booster shot of 0.5ml not 0.25ml). On 29-Oct-2021, ACCIDENTAL OVERDOSE (5 patients received a Moderna booster shot of 0.5ml not 0.25ml) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Medications were provided by the reporter  No Treatment Information were provided by the reporter
Information has been received from a physician concerning an approximately 11 or 12 year old male who in August 1995, was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Concomitant therapy included montelukast sodium (MSD). In 2006 the patient developed shingles under arm and lasted for approximately 2 weeks. At the time of report, the patient had full recovery from shingles. Unspecified medical attention was sought. a product quality complaint was not involved. Additional information has been requested.
Her eyes and head hurt; Felt like vomiting and having diarrhea; Hands and feet were shaking; Walking makes her dizzy; Felt like vomiting and having diarrhea; Chills; Her eyes and head hurt; Hurts too much where she had the injection; Injection site swollen and full of liquid; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Mar-2021 and was forwarded to Moderna on 05-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), HEADACHE (Her eyes and head hurt), EYE PAIN (Her eyes and head hurt), VOMITING (Felt like vomiting and having diarrhea), DIARRHOEA (Felt like vomiting and having diarrhea), TREMOR (Hands and feet were shaking), INJECTION SITE PAIN (Hurts too much where she had the injection), INJECTION SITE SWELLING (Injection site swollen and full of liquid) and DIZZINESS POSTURAL (Walking makes her dizzy) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced CHILLS (Chills), HEADACHE (Her eyes and head hurt) (seriousness criterion medically significant), EYE PAIN (Her eyes and head hurt) (seriousness criterion medically significant), VOMITING (Felt like vomiting and having diarrhea) (seriousness criterion medically significant), DIARRHOEA (Felt like vomiting and having diarrhea) (seriousness criterion medically significant), TREMOR (Hands and feet were shaking) (seriousness criterion medically significant), INJECTION SITE PAIN (Hurts too much where she had the injection) (seriousness criterion medically significant), INJECTION SITE SWELLING (Injection site swollen and full of liquid) (seriousness criterion medically significant) and DIZZINESS POSTURAL (Walking makes her dizzy) (seriousness criterion medically significant). At the time of the report, CHILLS (Chills), HEADACHE (Her eyes and head hurt), EYE PAIN (Her eyes and head hurt), VOMITING (Felt like vomiting and having diarrhea), DIARRHOEA (Felt like vomiting and having diarrhea), TREMOR (Hands and feet were shaking), INJECTION SITE PAIN (Hurts too much where she had the injection), INJECTION SITE SWELLING (Injection site swollen and full of liquid) and DIZZINESS POSTURAL (Walking makes her dizzy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Body temperature: 99.6 (High) 99.6 Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included PARACETAMOL   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient went to ER on 5/12/10 c/o increased fever, coughing, shaking, pain over most of body, headache, SOB, soreness at site.  MD examined and discharged pt.
Pt recvd vax 28FEB92 & 23MAR92 pt presented to MD w/complaint of having petechiae in the area of the body where clothing would be constrictive; hemorrhage in lt eye & presented to MD; dx vasculitis;
Woke up with itching, tightness, hot to touch, redness, firmness to left upper arm at injection site  Rubbed the area
pt recvd vax;exp extreme pain at inject site which lasted more than a week;devel much swelling, bruising, redness & swollen lymph nodes in arm; 20may94 pt still exp soreness at inject site;
02/12/23 presents to ED for "fatigue". PMHx of "MS, DM II, HTN"
pt recv vax 30JUL96 & 1AUG96 pt exp heavy head, which progressed to tightness by second day which pt felt might be change in the weather or sinus condition;devel inner ear infect & feeling bad;vertigo & flu-like sx was hot;stuffed up sinus
3 year 8 month female received dose of child's Pfizer COVID-19 Vaccine
woke up 5 days p/vax w/parotitis, low grade fever, nausea, pain around mouth, jaw & under ear; much worse the next day; saw ER MD was told had vax induced mumps; given Cephalexin;