chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a child was given PENTACEL but only given the liquid portion not the powder/ no AE; Initial information regarding an unsolicited non-valid non-serious case was received on 06-Jul-2021 from a Other healthcare professional via Medical Information (Reference number- 00670899) and transmitted to Sanofi on 06-Jul-2021.  This case involves a four-month-old male patient who while receiving DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] it was reported that child was given PENTACEL but only given the liquid portion not the powder with no adverse event (product preparation error).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylactic vaccination.  On 02-Jul-2021, the patient received 0.5 mL (total) dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [lot UJ4400AA and expiry date 29-May-2022] via intramuscular route in left upper thigh for prophylactic vaccination.  It was a case of actual medication error due to active ingredient not added to diluent (latency was on same day).  It was reported that, "Caller stated on 7/2/21 a child was given PENTACEL but only given the liquid portion not the powder. Caller wanted to know if the child will need to be given another dose or does the child just need the HIB part. PENTACEL. Product used: Used. First time product used: Yes. Still using product: No."  At the time of reporting, patient had no 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 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.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 62 year old African American, Not Hispanic-Latino female. The patient's height, and weight were not reported. The patient's past medical history included: covid-19 (previous to receiving the first Covid 19 dose), and concurrent conditions included: asthmatic, so problematic when had Covid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A31A and expiry: UNKNOWN) dose was not reported, 1 total, administered on 28-APR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported.  On DEC-2021, patient got Covid (omicron variant), real bad (suspected covid-19 infection and suspected clinical vaccination failure). Patient was scheduled for monoclonal antibodies, but could not find. Hence steroids were given. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000216498.; Sender's Comments: V0. 20220217797-covid-19 vaccine ad26.cov2.s--suspected clinical vaccination failure . 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: SPECIAL SITUATIONS.
3rd Varicella given accidentally. Previous dose, #1 not properly recorded, discovered previous count 3 given.
About 11 p.m. on July 28th I started vomiting, having stomach cramps ,back cramps ,headache ache ,and fever and I felt like I was smothering. My arm is so swollen and painful to the point where I have to use my other arm to lift it.
pt recv vax & devel a large area of cellulitis (area of rxn spread 3x the initial size) tx w/keflex po;rxn resolved p/1wk;this is 1 of 8 patients from this facility who exp the above rxn
Information has been received from a registered nurse for the Pregnancy Registry for GARDASIL concerning a 28 year old female patient with no pertinent medical history, no drug reactions/allergies, who on 03-AUG-2007 was vaccinated intramuscularly with the first 0.5 mL dose of GARDASIL (Lot # 658222/0927U). There was no concomitant medication. On 05-OCT-2007 the patient was vaccinated intramuscularly with the second 0.5 mL dose of GARDASIL (Lot # 658563/1063U). The patient became pregnant after receiving her second dose of GARDASIL. Her LMP was on 19-APR-2008 and estimated date of delivery was 24-JAN-2009. On 19-JAN-2009 the patient delivered by caesarean section. Upon internal review, patient delivered by caesarian section was determined to be an other important medical event. Additional information has been requested.
Got shot @ 10:00 am in right deltoid, saw rash on right arm @ 12 noon red, small bumps bottom 1/2 of arm underneath. No breathing problems.
Lymph nodes in right armpit became swollen approx. 36 hours after injection.  The area became very tender and painful.  The injection site also became painful, warm to touch and slightly swollen.  The lymph nodes on the my neck were also bothersome and gave me a constant headache for 3 days. Starting Sunday, 4 days post 2nd vaccine, I found 6 red spot on the side of my torso.  Same side of body as the vaccine.  It's not itchy, just there.  Day 4, still experiencing muscle aches in back and arm.
Covid arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 008B212A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced VACCINATION SITE REACTION (Covid arm). At the time of the report, VACCINATION SITE REACTION (Covid arm) outcome was unknown. Not Provided          Concomitant product information was not provided.  Treatment information was not provided.    This case was linked to MOD-2021-260311 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Second dose details added.
5/21/09 Midmorning patient developed a fever and sweats (soaked clothes), dizziness and felt like she would blackout if stood up. Also started menstrual period with cramps- took MIDOL. PHN recommended take TYLENOL for fever and call MD if symptoms persist. 5/26/09 phone call with patient- she felt it was a combination of the shot, cramps and MIDOL. Did not see medical provider. Slept all day and was fine.
I?ve had a rather dull ringing/tinnitus in my left ear for years which comes and goes, but the past could weeks since I got my 2nd dose of Pfizer COVID-19 vaccine, the ringing has been way louder and a lot more persistent. It fades quite a bit sometimes, but is way more noticeable than ever before. I am thinking it may be related to the vaccine as nothing else in my diet/routine has changed recently and I feel great otherwise.
After about 5 minutes after the vaccine was administered to my Girlfriend, she began to have a seizure while sitting upwards in her seat. The seizure lasted for about 5-10 seconds, and when she was done having the seizure, she could not remember what had happened, where she was, etc.  Happened right after she came out of the Pharmacist's office for the COVID-19 vaccine. She has taken other vaccines before, and even birth control via the shot and has been just fine.  She recovered from the seizure after about 10-15 minutes, and we stayed an extra 30 minutes at the vaccination site for any other side-affects.
I feel like crap, side effects; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling bad in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 21-APR-2023, the patient received the 2nd dose of Shingles vaccine. On 21-APR-2023, less than a day after receiving Shingles vaccine, the patient experienced feeling bad (Verbatim: I feel like crap, side effects). The outcome of the feeling bad was not resolved.   It was unknown if the reporter considered the feeling bad to be related to Shingles vaccine.     It was unknown if the company considered the feeling bad to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 21-Apr-2023. The patient reported this case via interactive digital media. The patient had his/her final vaccine in morning on day of reporting, so now the ads were coming. The patient felt like crap at the time of reporting, hope the side effects go away soon.
This spontaneous report was received from a healthcare worker via company representative regarding a 19 year old female patient. The patient's pertinent medical conditions, drug areactions and concomitant medications were unknown. On unknown dates in 1998, 1999 and 2003, the patient was vaccinated with hepatitis B vaccine (manufacturer unknown) (also reported as possibly manufactured by the company) (dosing details and lot # were not reported) for prophylaxis. On an unknown date, the patient underwent unspecified laboratory tests and the results were hepatitis B was not reactive (hepatitis b antibody negative). Outcome of the event was not reported. Causality of the event was not reported. No product quality complaint.
AT 14 MINUTES 30 SECONDS POST INJECTION, PT WAS DIZZY, LIGHT HEADED, LOSS OF BALANCE, DISORIENTED, PALE, SOME TINNITIS, CLAMMY AND COOL TO THE TOUCH . PT RESPONDED QUICKLY TO ORAL INTAKE OF WATER AND HARD CANDY AND ICE PACK TO THE BACK OF THE NECK.  PATIENT RECOVERED ENOUGH WITHIN 15 MINUTES TO GO HOME WITH ADULT WHO ACCOMPANIED HIM.
Received Hib vaccine and within 1-2 hours pt was lethargic, warm, and sleep was very disrupted for the next 2 nights. Lethargy remained consistent for 2-3 days. Child is normally hyperactive and this change was very concerning to the parents. Reduced appetite for 1 day, fever to 101 F for <24 hours. Minimal injection site redness
27NOV96 both arms ache, h/a, unable to get out of bed, fever, chills, sensitive to light, fever 2-3 days, p/2-3 days pain in arms settled in armpits for 2-3 days-arms were red & very warm to touch;
Right upper arm swelling and itching noted after giving vaccination in addition to redness that has persisted for 48 hours. Parent reported that patient had a similar reaction during last dose of DTAP in 2015. Prescribed ibuprofen and diphenhydramine. Recommended continued itching of area.
Takotsubo cardiomyopathy; This is a literature report for a Pfizer sponsored program.  A 68 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Unknown manufacturer), for COVID-19 immunisation. The following information was reported: CARDIOMYOPATHY (hospitalization, medically significant), outcome "unknown", described as "Takotsubo cardiomyopathy". The patient underwent the following laboratory tests and procedures: arterial catheterisation: (unspecified date) normal, notes: normal coronary arteries without obstruction; blood test: (unspecified date) normal, notes: Blood work was normal; echocardiogram: (unspecified date) estimated ejection fraction (ef) of, notes: estimated ejection fraction (EF) of 30-35%,as well as kinesis of the apical septal, apical inferior and apical myocardium; (unspecified date) improvement in ef (55-60%),, notes: Further, a follow-up TTE after 8 weeks revealed improvement in EF (55-60%), without wall motion abnormality; electrocardiogram: (unspecified date) t wave inversion in the inferior and lateral leads, notes: Normal sinus rhythm with diffuse T wave inversion in the inferior and lateral leads, a new development in comparison; (2017) t wave inversion in the inferior and lateral leads, notes: a new development in comparison to a previous EKG in 2017; troponin: (unspecified date) 0.465, notes: troponin levels of 0.465[unit not stated].  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the Limited information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Mild shortness of breath, dizzyness and palpatations. Subjective feeling og throat swelling.
I experienced terrible sore throat, ear ache, neck pain, tiredness, weakness, coughing, runny nose and fatigue.
Got vaccine at 1:15.  At 1:27.  Became very hot, red rash all over, tachycardia .  I alerted the nurse and at that time my watch was beeping afib.
GARDASIL given 3/17/2009. Patient got headache and vomiting on 3/19/2009 and 3/20/2009.
just got the new Moderna booster and it felt like I got mosquito bites on my arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (just got the new Moderna booster and it felt like I got mosquito bites on my arm) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported. On 16-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 16-Sep-2022, the patient experienced VACCINATION SITE PAIN (just got the new Moderna booster and it felt like I got mosquito bites on my arm). At the time of the report, VACCINATION SITE PAIN (just got the new Moderna booster and it felt like I got mosquito bites on my arm) outcome was unknown.    No concomitant medications were reported. It was reported that, the patient got booster and it felt like mosquito bites on arm. It was unknown, if the patient had mosquito bite. No treatment details were reported.
This spontaneous report as received from a 74 Year old female patient with no drug reactions or allergies. On 15-APR-2008 the patient was vaccinated with a dose of ZOSTAVAX, "1 time vaccine", to prevent shingles; lot # and dose not reported. Concomitant therapies included LIPITOR and "low thyroid medication". On approximately 20-MAR-2014 (reported as "about two weeks ago") the patient developed shingles. She stated that she got the shingles on her right breast, between both breasts and her "scapula". The patient sought unspecified medical attention and was given antivirals, pain medication and "prednisone". The outcome of the adverse effect was not reported. Relatedness between use of ZOSTAVAX and shingles development was not reported. Additional information has been requested.
Seizure-like activity while nursing 2 days after vaccinations: shaking for a few seconds followed by a sudden loss of tone with cessation of breathing and eyes rolling to the back of the head. Patient then presented to Emergency department with mother for treatment. ECG was performed with no remarkable findings. Patient was discharged with instructions to return if symptoms recur.
Dizzy and briefly fainted about a hour later. Next day vomiting, aches, fever (100.4), chills, dizzy, muscle and joint pain, patchy red skin all over body, feeling exhausted and dehydrated.
This spontaneous report was received from a female consumer refers of unknown age who refers to herself. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot# not reported). It was reported that after receiving the vaccine, on an unknown date the patient experienced redness and pain at the injection site. The outcome of redness and pain at the injection site was unknown. Additional information is not expected.
Injection very swollen. Started as small area and now is 7? long and 3.5 inches wide. Very hot and itchy.  Also had chills first night and have had 102.2 temp each day when I wake up.  Temp goes back to normal as I move around.
took the flu shot and has the flu now; Initial information received on 03-Jan-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age male patient who took the flu shot and has the flu now.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a Unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, Strength, formulation, Expiry date was not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient took the flu shot and has the flu now (influenza) (unknown latency).  It is unknown if there were lab data/results available.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
11/21/11 - Vaccine administered. 11/22/11 - Phone call from parent reporting (+) swelling (+) itching (+) discomfort. Swelling from site of injection to knee, unable to bear weight treated with antihistamine.
LOST SENSE OF SMELL; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure, alcohol use, and non smoker, and other pre-existing medical conditions included: The patient had no known drug allergies and had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced lost sense of smell. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) high-controlled. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of lost sense of smell was not reported. This report was non-serious.
I received the 2nd dose of the Moderna vaccine for Covid 19, and 2 days later started menstruating with heavy non stop bleeding, and cramping. Lasted 3 days. I have been in Menopause for 18 months or longer and have not had any bleeding until after this vaccine. I went to my OB for an evaluation & biopsy, waiting on results.
Received VARIVAX on 12/21/11. On 12/22/11 at 12:00 pm post. Lt. forearm sore and redden. Feet itchy, warm and painful.
Mom reported that patient developed a rash over his right thigh yesterday evening after having received 2 vaccinations in the right thigh in clinic earlier.  She denied any itching, fever, or abnormal behavior.  Recommend diphenhydramine to help with resolution of the rash.  If it begins to spread or become worse please call and asked for an urgent care appointment.
Patient felt dizzy and nauseous shortly after receiving the vaccine. She lay down on the floor and we instructed her to raise her legs.  She did not actually pass out. After about 10 minutes she felt well enough to sit up and was given some orange juice. She recovered without any other issues.
THE PATIENT FELL ON THE FLOOR AS HE WAS GETTING OUT THE OF VACCINE ROOM AND THE WTINESS REPORTED THAT HE WAS SEIZING. 911 WERE CALLED IMMEDIATELY AND EMT CAME AND PICKED UP THE PATIENT
product was expired at the time of administration with no reported adverse event; Initial information received on 18-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 59 years old female patient who was administered vaccine expired at the time of administration with no reported adverse event after receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Prophylactic vaccination; and HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Prophylactic vaccination.  On 18-Jul-2022, the patient received a  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE( lot UJ542AAAand expiration date: 10-Jul-2022) at a dose of 0.5ml via unknown route in the left deltoid for immunization.  On 18-Jul-2022 (latency: same day),the patient was administered vaccine expired at the time of administration with no  reported adverse event (expired product administered). The patient needed the vaccine for a stem cell transplant.  Action taken: Not applicable  It was not reported if the patient received a corrective treatment for the event   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.
Within 24 hours had redness and swelling at injection site. It has worsened over the past 6 days with the redness wrapping around my arm and extending to the elbow. Hot, swollen and now painful.
Patient said "nerve pain started in arm and extended to shoulder and collar bone area on the same side as shot received"
PATIENT DEVELOPED FLU LIKE SYMPTOMS SUCH AS CHILLS, BODY ACHES, NAUSEA, WEAKNESS, DIZZINESS.
Jansen COVID-19 Vaccine EUA   7am, headache down through shoulders, pain at site 9am, severe chills and chattering, white lips pale skin 3pm muscle body aches, 101 fever
Extreme pain in left arm, extreme fatigue, nausea, dizziness, body aches
8:00pm started feeling sick, started getting sore throat  Next morning around 7am very sore throat, beginning of muscle aches Slowly progressing throughout the day, tired, muscle aches, soreness at injection site, sore throat, possible fever (unable to confirm)
Information has been received from a physician concerning an infant patient with no illness at time of vaccination or pre-existing allergies, birth defects and medical conditions who on 05-APR-2010 was vaccinated orally with the first dose of ROTATEQ (Lot# 664076/0768Y) at 19:00. On 06-APR-2010 the patient developed blood in the stool which persisted > 10 days. Lab data: rotavirus antigen positive in stool and bacterial culture was pending. At the time of report the patient's status was unknown. Upon internal review, blood in the stool was considered to be an other important medical event. Additional information has been requested.
DURING ADMINISTRATION, NEEDLE WASNT SECURELY SCREWED ONTO THE NEEDLE AND WHEN THE PLUNGER PRESSED, MAJORITY OF THE VACCINE WENT DOWN THE PATIENTS ARM, ON THE FLOOR, AND ONTO HIS FACE.  HE NEVER FELT ANY VACCINE GO INTO HIS ARM.  WE ADMINISTERED THE VACCINE AGAIN (FULL DOSE).  PATIENT VERY UNDERSTANDING ABOUT THE ERROR.