chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient received an expired dose of ACT-HIB with no reported adverse event; Initial information received on 12-Oct-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves 4 years old male patient who received an expired dose of haemophilus type B (HIB) (PRP/T) vaccine [ACT-HIB] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included measles vaccine live (enders-edmonston), mumps vaccine live (JERYL LYNN), rubella vaccine live (WISTAR RA 27/3), varicella zoster vaccine live (OKA/MERCK) (Proquad) for Immunisation; and diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, polio vaccine INACT 3V (MRC 5), tetanus vaccine toxoid (Quadracel) for Immunisation.  On 11-Oct-2023, the patient received a standard expired dose 3 of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection at a dose of 0.5 ml (lot UJ798AA) (with an unknown strength and expiry date) via intramuscular route in the right thigh for Immunization with no reported adverse event (expired product administered) (latency- same day). Caller asked Is the dose okay or do it need to be repeated?  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 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.
Didn't star reactions until about 18 hours after vaccine.. Fever, arm pain in site of injection, achy, tired, dizziness, nausea, amd till today still feel not right.
Both with my 2nd. Covid shot on 4/23/21 Pfizer ER8729 given at Pharmacy & the Pfizer booster shot on 11/20/21 I had left axilla/underarm swelling that extended to breast tissue & was obviously swollen compared to the right breast & breast tissue raised up enough that I could feel the swelling in the way when using/moving my left arm. This lasted 3-4 days. All 3 of my shots have been Pfizer & given in my left arm.
Shortly after receiving the shot, patient feel dizzy, pale and sweating; her bp decrease to 85/62; I has her took off her mask; by talking to her and comforting her, after 30 min she felt better; her bp went up to 125/85;
pt says he had headache, fever, chills, leg pain and SOB.  Pt is feeling some better but still has a headache.  Pt wants to know if it is safe to take aspirin in case of chance of getting blood clots. Pt will contact his PCP for medical advice.
headache, chills, low grade fever, lower back pain, neck pain, diarrhea
The diluent was not mixed with the lyophilized menA component, so only the C/W/Y component were given. No known adverse reactions to the vacine.  Will be boosted with the full series at a later date.  Family aware. This is a known difficulty with administration of vaccines that require using 2 vials.
Chills, body ache, fatigue, weakness beginning two days after injection and continuing for ten days (as of today's date). Ibuprofen Symptoms are ongoing.
pt became limp & lips cyanotic p/vax; was totally unresponsive for about 1-2 mins but showed no resp distress; BP 90/42; seen by MD in clinic & referred to ER; ER MD stated reaction was not an anaphylactic reaction but syncope; pt was listl
Child awoke alert from afternoon nap.  Had a diaper change and was placed in his high chair for a meal. Moments after, child went into a staring seizure and was unresponsive.  I was notified by caregiver (grandmother) and the ambulance was also notified.  Child remained in the unresponsive state for about 5 minutes (right before the paramedic was to administer something to bring him out).  There were no signs leading to this.  He was taken to Hospital.  Received a CT scan that evening.  No seizure medication was given.
pt recvd vax & had a syncopal  or vasovagal episode; pt recovered w/o any residual effects; No further detials were provided; MD reported 20 pts;
Widespread rash, morbilliform, blanching, concentrated on the anterior abdomen up to thorax. Some on legs, face and back. Vaccinated with MMR on 8/29/11. Started with symptoms on 9/8/11. TYLENOL for pain and BENADRYL 3/4 to 1tsp every 12 hrs.
I developed a severe blood clot in my left calf. I needed to be admitted in the hospital. I was there for 4 days.
STARTED TO FEEL SOME ITCHING IN BOTH EARS,THROAT GOT DRY AND WAS NOT ABLE TO SWALLOW WITH 20 MINUTES OF THE VACCINE. i WAS INJECTEWD WITH AN EPIPEN , WAS GIVEN BENARYL AND STEROID AND WAS CARRIED BY AN AMBULACE.
0902 C/O of lightheaded, 72 P, 20 R, 119/72 @ 0912. Pt stated feeling faint, noted paleness & diaphoretic. 0911 Pt stated feeling better, noted color is now pink, no longer diaphoretic. 0917 Pt stated he would like to leave. 0919 Pt left on his own.
Received first dose and less than 18 years of age; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received first dose and less than 18 years of age) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 05-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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received first dose and less than 18 years of age). On 05-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received first dose and less than 18 years of age) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter did not allow further contact; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old female) for mRNA-1273 (lot number 027A21A) with no associated AEs reported.
on 2nd day arm swollen same on third day arm swollen even more had itching, fever in arm, pt states felt dizzy & sick feeling; pt was sent to see MD;
patient in office for 12 month WCE. patient  record showed patient due for MMR, Varivax, DTaP, Hib, Hep A and PCV13 . Medical assistant working in office mistakened MMR with MMRV, there for the patient received a double dose of varicella. patient received both varivax and mmrv in same day.  no adverse reaction at this time. family notified with instruction and home care advise.
Patient states that pain occurred in left arm the day after receiving the vaccine and the arm pain has not improved after over a month. She also notices reduction in range of motion and muscle strength in her left arm as well.
loss of appetite; arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain) and DECREASED APPETITE (loss of appetite) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included CARBOHYDRATES NOS, CHOLESTEROL, FATS NOS, MINERALS NOS, POTASSIUM, PROTEIN, SODIUM, VITAMINS NOS (GLUCERNA ADVANCE) for Diabetes mellitus.    On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm pain). On 16-Feb-2021, the patient experienced DECREASED APPETITE (loss of appetite). On 10-Feb-2021, PAIN IN EXTREMITY (arm pain) had resolved. At the time of the report, DECREASED APPETITE (loss of appetite) outcome was unknown.            Treatment medications were not provided by reporter.
Swollen/hot area around injection site. Dr. did not think this was true allergic reaction. Dr. recommended ice on arm and come back Friday. Local reaction.
ACCIDENTALLY ADMINISTERED TWO DIFFERENT COVID 19 VACCINES; This spontaneous report received from a health care professional concerned a 40 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and other pre-existing medical conditions included the patient had no known drug allergies. the patient did not have any history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1816027, and expiry: UNKNOWN) .5 ml, administered on 07-MAY-2021 10:00 for prophylactic vaccination. Concomitant medications included mrna 1273 for prophylactic vaccination. On 07-MAY-2021 10:00, the subject experienced accidentally administered two different covid 19 vaccines. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of accidentally administered two different covid 19 vaccines was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non serious.
pt recv vax 8JAN97 & was in 10JAN97 in AM for PPD reading c/o redness;nurse noted small amount redness;pt states did use ice;later 10JAN97 got red under arm w/burning sensation down arm;MD advised irritation caused by needle used
4/1-Patient states she has seen slightly raised bumps on both legs and in cluster forms, first noticed on legs then started to travel up on arms and chest, she also feels a little nausea. Patient took antihistamine (Diphenhydramine) but noticed no relief therefore discontinued (took once). Since notice of the bumps on Friday until Thursday 4/1/21 patient feels the bumps are getting worse and growing and not getting better.  4/5-Patient continues with raised bumps on bilateral lower extremities. Patient has applied cortisone cream with no relief. She has made an appointment to see her general practitioner sometime this month.
22MAY93 devel a single rash like lesion on 1 ankle; later devel rash on legs which progressed toward stomach, back & face & neck; 12-14 days p/vax hospitalized for dehydration; rash was vesicular & macular;
General symptoms: Chills, joint pains, muscle pains, fatigue. Narrative:
I seem to have what is termed "Covid arm".  It does not itch, nor does it hurt.  There is just a red box around the injection site.  It has now been almost 2 weeks.  I am scheduled for my next vaccine in about 2 1/2 weeks.
I started having pain in my left shoulder across my back and down my arm into my left hand. It is getting progressively getting worse. both shoulders are so painful and I cannot grip anything in my left hand. My fingers on my left hand are going numb. I've been alternating taking tylenol and ibuprofen but they are not helping at all.
No additional AE information reported; Nurse reporting administration of improperly stored GARDASIL 9.; This spontaneous report was received from a nurse and referred to a patient of unknown age and gender. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 15-JUN-2022, the patient was vaccinated with improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 1 dose, lot #U034201, expiration date was reported 21-NOV-2023, upon internal validation established as 21-OCT-2023, administered for prophylaxis (strength, and route of administration were not provided) (product storage error). The patient was aware of this event.  It was reported that the suspect vaccine was exposed to a temperature of minus 24 degree Celsius for a time frame of 1500 hours (2 months, from 14-APR-2022 to 15-JUN-2022). There were no previous temperature excursions.   No additional adverse event (AE) information was provided.
This spontaneous report as received from a consumer concerning her daughter's cousin of unknown age and gender. On unspecified date, the patient was vaccinated with M-M-R II dose 1 (lot #, route and dose not reported). The reporter informed that her daughter's cousin had a seizure "days after" receiving M-M-R II at an unspecified time. At time of reporting, the patient's outcome of seizure was unknown. Upon internal review convulsion was considered to be medically significant. Additional information has been requested.
Fever of 100; back hurts; arm sore at the injection site; joint aches; Very Tired; muscle aches; This spontaneous case was reported by a patient and describes the occurrence of BACK PAIN (back hurts), VACCINATION SITE PAIN (arm sore at the injection site), PYREXIA (Fever of 100), ARTHRALGIA (joint aches) and FATIGUE (Very Tired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Fever and Back pain.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced VACCINATION SITE PAIN (arm sore at the injection site), ARTHRALGIA (joint aches), FATIGUE (Very Tired) and MYALGIA (muscle aches). On 10-Mar-2021, the patient experienced BACK PAIN (back hurts) and PYREXIA (Fever of 100). The patient was treated with PARACETAMOL (TYLENOL) on 10-Mar-2021 for Fever and Back pain, at a dose of UNK dosage form. On 07-Mar-2021, VACCINATION SITE PAIN (arm sore at the injection site), ARTHRALGIA (joint aches), FATIGUE (Very Tired) and MYALGIA (muscle aches) had resolved. On 10-Mar-2021, BACK PAIN (back hurts) and PYREXIA (Fever of 100) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Body temperature: 100 (High) high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient had two COVID-19 tests  a year before the report and both came negative.  Concomitant medications was included Antibiotics.   This case was linked to MOD-2021-143535 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow-up information received on 18-May-2021 reporter details captured.
Patient presented to emergency department on 9/16/2021 with shortness of breath. Reports symptoms started 9/6/21 and was tested for COVID-19 at an urgent two days prior to presentation. Covid-19 infection was confirmed and patient was admitted for further management. She was treated with remdesivir, dexamethasone, and supplemental oxygen. Patient improved and was discharged home on 9/20/2021.
Patient received an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 16-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 229AN, expiry date 5th July 2022) for prophylaxis.   On 9th August 2022, the patient received Boostrix. On 9th August 2022, unknown after receiving Boostrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 16-AUG-2022 Reporter's Comments: The pharmacist reported that a patient received an expired dose of Boostrix on 9th Aug2022. The Boostrix expired on 5th Jul2022. The reporter gave consent to follow up. Additional Supportive Information: The patient received expired Boostrix vaccine, which lead to expire vaccine used. This case is linked to the case US2022119632, reported by the same reporter; Sender's Comments:  US-GSK-US2022119632:Same reporter. Patient 1.
On 2/2/18 father came because son was complaining of itchiness on left deltoid where vaccine was given. When exam patient arm notice skin red, warm to touch. Measurements W 4.5 cm and L 5 cm.
This child had large erythema (from the hip to the knee) at the site if the injection.
left arm was sore; received vaccine with a yellow brownish color; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left arm was sore), PRODUCT COLOUR ISSUE (received vaccine with a yellow brownish color) and FATIGUE (Fatigue) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN IN EXTREMITY (left arm was sore), PRODUCT COLOUR ISSUE (received vaccine with a yellow brownish color) and FATIGUE (Fatigue). On 17-Mar-2021, PRODUCT COLOUR ISSUE (received vaccine with a yellow brownish color) had resolved. At the time of the report, PAIN IN EXTREMITY (left arm was sore) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.  No concomitant medications and treatment were reported.
I started having uncontrolled leg twitching. All over my legs. Sometimes its worse or better. I have been to my general doctor, spine doctor and Nuerologist and all have ruled out the big things; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 27Apr2021 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The patient previously took acetylsalicylic acid (ASPIRIN) for unknown indication on unknown date and experienced drug allergy. It was not reported if patient took any concomitant medication taken within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Jun2021, the patient started having uncontrolled leg twitching. All over her legs. Sometimes it was worse or better. The event resulted in doctor or other healthcare professional office/clinic visit. The patient had been to her general doctor, spine doctor and Nuerologist and all had ruled out the big things like restless legs syndrome (RLS), electrolyte deficiencies and neurological problems. No therapeutic measures were taken as a result of the event. Since the vaccination, the patient had been tested for COVID-19. On 23Jun2021, the patient underwent COVID- 19 test via nasal swab and the result was negative. The clinical outcome of the event started having uncontrolled leg twitching, all over legs; sometimes it was worse or better was not resolved at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
None immediately,  On 9th day after arm is sore, red and swollen (large area) at injection site and a little itching.
Patient came County Health Dept. for Pfizer CV-19 vaccine accompanied by his mother. Additional family members in attendance. Looked at birth year, 2017, and mistakenly calculated that patient was five. Patient is 4 years, 10 months old. Gave 0.2 ml of properly diluted Pfizer-BioNTech Peds COVID-19 Vaccine in child?s left deltoid. Patient waited for 15 minutes in the lobby with family members without any adverse reactions. No signs or symptoms of acute distress. Patient left with family. Mother made aware County Health Dept. supervisor that the patient should not have received the vaccine. Mom reports no reactions at time of call.
I had the vaccine at 1pm. Exclusively Breastfed 8 month old baby had diarrhea (very smelly loose stools)  around 3:30pm. (He has had diarrhea after his infant vaccinations). By evening he also had a temperature of 99.5.
Went to hospital for treatment of whole body aches. Given Motrin 800mg. No other problems found during exam.
Chest pains beginning around 48 hrs after vaccine administration and ending around 2 weeks after receiving vaccine. Shortness of breath at night while sleeping for approximately two weeks after receiving vaccine.
Headache; Fall; This spontaneous case was reported by a consumer and describes the occurrence of FALL (Fall) and HEADACHE (Headache) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products TREPROSTINIL DIOLAMIN (ORENITRAM) for Pulmonary arterial hypertension and TREPROSTINIL for Pulmonary arterial hypertension.    Concurrent medical conditions included Pulmonary arterial hypertension.   On 28-Jul-2021, the patient TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) dosage was changed to .25 mg every eight hours and TREPROSTINIL (Oral) dosage was changed to 2 mg every eight hours. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form, TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) 1 mg every eight hours On an unknown date, TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) dosage was changed to 2.5 mg every eight hours, TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) dosage was changed to 2 mg every eight hours and TREPROSTINIL (Oral) 2.5 mg every eight hours. and TREPROSTINIL (Oral) dosage was changed to 3 mg every eight hours. On 09-Sep-2021, the patient experienced FALL (Fall). On an unknown date, the patient experienced HEADACHE (Headache). In September 2021, FALL (Fall) had resolved. At the time of the report, HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, Computerised tomogram: normal (normal) did not break anything.         No treatment information was provided. No concomitant medication was provided
6/5/01 child had a left localized seizure that progressed and ? ? ? went to WMC ??? White Plains Hosp. Seizure lasted greater then 30 minutes as per neurologist - neurologically normal.
Patient was extremely light headed, clammy, and dizzy. She never lost consciousness, but said she felt like she may pass out.
A nurse reported a 20 month old male received an injection of Acel-Immune on 4/12/00. The next day, the patient developed an injection site reaction characterized by a "silver dollar" sized area of redness and swelling. The patient recovered. This is 1 out of 3 patients from this facility who developed an injection site reaction following the receipt of Acel-Immune lot 469-396.
First the injection site bleed a lot, then a subcutaneous hematoma about 1  1/2 inches in diameter developed. As night came on my arm ached more than the first injection event and then my whole body started to ache. It was a night of little sleep due to the aches all over the body. The next day it was like I had a very bad flu, there was a bad headache, body aches, heart hurt and I kept having to empty the bowels and couldn't eat or drink much. Later in the day I threw up everything. Was feeling a little better by 2 days later, but even now am not up to previous energy levels.
Information has been received from a consumer concerning her cousin's 15 year old son who was vaccinated with MMR II (lot number not available) when he was 18 months old. The patient started to slowly become autistic after the vaccination (age at onset not reported). It was noted that the patient has severe autism but other than that, he was fine. Unspecified medical attention was sought. A hearing test was performed (results not provided). At the time of this report, the patient's severe autism persisted. No further information is available.