chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a 3 month old male received Fluzone Quadrivalent 0.5 mL on 27Nov2019 in error and the consumer was to get the Prevnar vaccine instead; a 3 month old male received Fluzone Quadrivalent 0.5 mL on 27Nov2019 in error and the consumer was to get the Prevnar vaccine instead; Initial information received on 27-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.   This case involves a 3 months old male patient who received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] instead of PREVNAR and reported that a 3 month old male received Fluzone QUADRIVALENT 0.5 ml on 27nov2019 in error and the consumer was to get the Prevnar vaccine instead (wrong product administered) and (product administered to patient of inappropriate age).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 27-Nov-2019, the patient received a dose of suspect 0.5 ml INFLUENZA QUADRIVAL A-B VACCINE (lot UT6656NA and expiry date: 30-Jun-2020) via intramuscular route in the left thigh.  It was a case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration.  It was unknown if 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.
Pt vax /w DTP/OPV parents noted scream, the became limp & gray as existed building retained for eval. Normal exam responsivness noted by nurse.
Fully vaccinated.  COVID infection breakthrough and inpatient hospital stay for planned csection of full term baby Baby boy delivered 12/16/21   8# 7oz
Swelling right arm Although patient has breast cancer, no lymphnodes were removed during surgery over 5 years prior. Swelling persisted since 60 days (estimated) after injection dose #2. Both doses were given in right deltoid.
VARIVAX vaccine was given 8/13/14 right arm sc pt returned to office today for PPD read and showed us her arm. 4 cm raised reddened area warm to touch saw provider for evaluation of area.
Case number PHEH2015US022702, is an initial and follow up spontaneous report received from a consumer on 30 Oct 2015 and 03 Nov 2015 (combined report). This report refers to an 82-year-old female patient. Medical history was not reported. Current conditions included lymphoma (battling for years). Concomitant medication was not reported. The patient received FLUVIRIN (batch number: 1515901, expiry date: May 2016) intramuscularly on 23 Oct 2015. On the same day after vaccination, the patient experienced fever of 102 F. The patient's oncologist told to take TYLENOL and the fever went down to 99 F but it was still not normal. The patient has been experiencing severe fever consistently for 12 days and also the patient feels very weak. Final outcome of the events was not recovered. Seriousness and causality was not reported.
Area of erythema, edema, warm. Tenderness left upper arm covering 1/3 of the area between shoulder & elbow. Central puncture site.
This case was reported by a other health professional via call center representative and described the occurrence of injection site rash in a female patient who received SHINGRIX for prophylaxis. On 11th June 2018, the patient received SHINGRIX. In June 2018, less than a week after receiving SHINGRIX, the patient experienced injection site rash, injection site erythema and injection site itching. On an unknown date, the outcome of the injection site rash, injection site erythema and injection site itching were not recovered/not resolved. It was unknown if the reporter considered the injection site rash, injection site erythema and injection site itching to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported the adverse event via web form. The healthcare professional reported that the patient came back on the day of reporting with a rash (red, size of 2 into 3 inches) at the side of the injection. The patient was informed that it was very common adverse effect and should be resolved soon but she would like to know how long it would typically take to get resolved and what could done to help it resolve faster and to manage overall itching and redness. No additional information was provided.
This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. No concomitant medication, patient's medical history, drug reactions or allergies were reported. On 03-MAR-2017 the patient was vaccinated with PNEUMOVAX23 (lot # K021881, route of administration, dose not reported), for prophylaxis. The nurse stated that the patient was administered an expired dose of the vaccine: expiration date 30-JUL-2016. No adverse events were reported. Additional information has been requested.
2 cm local reaction on (R) deltoid at the site of the injection. Patient advised to do OTC BENADRYL and Ibuprofen.
He had 4 COVID-19 vaccine shots from Pfizer and got COVID-19; He had 4 COVID-19 vaccine shots from Pfizer and got COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovered" and all described as "He had 4 COVID-19 vaccine shots from Pfizer and got COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Paxlovid Rebound symptoms of COVID-19, she already has the 4 doses of the Pfizer COVID-19 vaccine. Got COVID-19 virus two and a half weeks after getting second booster dose of COVID-19 Vaccine. Her husband took Paxlovid and he's fine. He had 4 COVID-19 vaccine shots from Pfizer and got COVID-19. Responded well from Paxlovid. Positive for COVID-19 after 4 doses of Pfizer COVID-19 Vaccines.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Error: Wrong Route (SC, IM, etc.)-, Additional Details: Selections made on what I was told by staff RPh, who observed injection site.
Throat swelling, face swelling and numbness, rash on legs and arm 30 minutes to an hour after vaccination, numb/tingling face still a month later  Treatment: Benadryl and then steroids and antihistamines at ER
After the first shot I started getting really hot and sweaty and I started shaking and I almost passed out. The EMT checked my heart and I had a rapid heartbeat. About 10 minutes it passed. After the second shot the same thing happened but it messed with the beating of my heart. There was an ER doctor there and he looked to my EKG and he saw some damage in my heart. He said it was probably because of the 2 heart attacks I have had in the past. Within 20 minutes he let me go but the next day I called my cardiologist and I went to see him. He told me the shot interfered with my heart beat and within a month it should go away, which it did. They had to put me back on a medication to help with my heartbeat.
Fainted followed by what I would describe as a seizure.  I stiffened.  Eyes rolled back.  Mouth gaped open.  I was out for a few minutes according to my husband.  He called 911.  My blood pressure was very low.  I was taken to the ER.
Patient received her vaccine  stood to wait for her sibling to receive the vaccine (per nurse administering vaccine). She then passed out and hit her head on the ground from a standing position. (per nurse administering the vaccine, I did not witness this but responded.) Additionally the timeframes listed on this report are close approximations. The patient came to consciousness immediately. However, she  had complaints of pain radiating from the back of her head to the front and down her spine. C-spine held. 911 called. C-collar placed on the patient. Patient transferred to the ER. No other symptoms or s/s of anaphylaxis noted.
DEVELOPED ITCHING, REDNESS  AND SWELLING TO INJECTION SITE AREA. STATES THIS BEGAN APPROXIMATELY 2 DAYS AFTER INJECTION. APPLIED ICE TO THE AREA, NO FURTHER TREATMENT SOUGHT. NOTIFIED EMPLOYER WHEN RETURNED TO WORK ON 1/09/2023.
Information has been received from a physician concerning a female adult who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included a dose of influenza virus vaccine (unspecified). Subsequently, the pt experienced neck pain. Unspecified medical attention was sought. There was no additional information regarding the pt's present status. No product quality complaint was involved. Additional information has been requested.
One week after receiving the vaccine I developed mild itching at my upper left arm. There was redness and warmth at that site, approx size of lime. The itching resolved quickly. I felt tired and the redness/warmth spread downward. It was checked and circled by a physician at an appointment for a different issue (knee)?plan to call if area of redness increases. It did, but I monitored and within 6 days it resolved.
Woke up at 11:30 p.m. with severe chills, burning up, could not think straight, dizziness and no balance and had to crawl to the bathroom.  This was combined with no energy.  This lasted until 8:30 a.m. in the morning.  and the fever lasted at least another 24 hours.  I took two Tylenol  caplets  by 8:00 a.m. and the chills subsided  somewhat but then continued 2 caplets at 12noon and 4:p.m. and again at night 8 p.m.   It was helpful w the severe headache and fever.  I was able to walk but slept most of the day.   By the 2nd day, felt somewhat better, but more at the end of the 2nd day.   Current residual problems are that my head feels heavy--there are no sinus problems.  My balance does not feel stable still though I am able to walk around and drive.
BONE PAIN; PAIN IN UPPER BODY; SIGNIFICANT FATIGUE; FEVER; FIRE WITH NEUROPATHY; VASOVAGAL RESPONSE/ BLOOD PRESSURE DROPPED; This spontaneous report received from a patient concerned a 49 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included stage 3B colon cancer, and chemo induced neuropathy. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, total 1 dose, administered on 05-APR-2021; at 13:30 for prophylactic vaccination. Concomitant medications included gabapentin for neuropathy, and pegfilgrastim (Neulasta).  The patient's strength was not fully back because of physical limitations caused by neuropathy. Prior to the vaccination, the patient was well hydrated and took 900 mg gabapentin. On 05-APR-2021, almost immediately after the vaccination, the patient had a vasovagal response and the patient's hand were on fire with neuropathy. The patient's blood pressure (BP) was dropped to 80/40, blood sugar and hydration were fine. The patient recovered in about 20 minutes and felt fine for about 5 hours. The patient went to bed early and woke up with a fever of 100.4 and developed bone pain, pain in upper body that rivals the Neulasta shot with chemotherapy. The patient took paracetamol (extra strength tynenol), was able to reduce the pain and went back to sleep. The same thing happened 5 hours later with the same response with Tylenol. 22 hours post injection, the patient was not on tylenol, and did not feel pain, but the patient did felt significant fatigue. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vasovagal response/ blood pressure dropped, bone pain, and pain in upper body, had not recovered from fire with neuropathy and significant fatigue, and the outcome of fever was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0;-covid-19 vaccine ad26.cov2. s-vasovagal response/ blood pressure dropped. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.  covid-19 vaccine ad26.cov2. s-fire with neuropathy. This event is considered not related. The event 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 than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE
Head went forward..eyes closed. Body stiffened. Seizure lasted about 30 seconds. Patient felt lightheaded after but was able to walk out of Health Department after resting for 10 minutes or so.
Approximately 1.5 weeks after vaccination, patient began to notice bruising to lower legs and feet, one bruise as "big as a coffee cup" on inner right knee. She was seen by her PCP on 4/21. Lab work done. No specific treatment other than observation.
pain in her arm; This is a spontaneous report from a contactable healthcare professional, the patient. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, second dose) solution for injection intramuscular on an unknown date (at an unknown age) at single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (first dose) for COVID-19 vaccination on an unknown date and experienced she felt really tired. On an unknown date, the patient experienced pain in her arm. The outcome of the event pain in her arm was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021093322 same drug/patient, different dose/AE
This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness / light headedness / woozy), BALANCE DISORDER (Felt like falling over), VACCINATION SITE BRUISING (Black and blue at injection site), VACCINATION SITE PALLOR (Pale pink oval at injection site) and ERYTHEMA (Red dots) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic (Cipro), Allergy to antibiotic (Bactrim), Penicillin allergy, Drug allergy (Sudafed) and Drug allergy (Opioids). Concomitant products included CALCIUM, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and LORAZEPAM for an unknown indication.    On 06-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 DIZZINESS (Dizziness / light headedness / woozy), BALANCE DISORDER (Felt like falling over), PALPITATIONS (Heart was thumping), FATIGUE (Fatigue), HEADACHE (Headache) and VACCINATION SITE PAIN (Stinging and burning at injection site). On 07-Mar-2021, the patient experienced VACCINATION SITE BRUISING (Black and blue at injection site) and VACCINATION SITE PAIN (Injection arm soreness). On 16-Mar-2021, the patient experienced VACCINATION SITE PALLOR (Pale pink oval at injection site), VACCINATION SITE PRURITUS (Itchy at injection site/had an itchy) and VACCINATION SITE SWELLING (Swelling at injection site). On an unknown date, the patient experienced ERYTHEMA (Red dots) and RASH (Swollen rash). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form and HYDROCORTISONE (CORTISONE [HYDROCORTISONE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizziness / light headedness / woozy), BALANCE DISORDER (Felt like falling over), VACCINATION SITE BRUISING (Black and blue at injection site), VACCINATION SITE PALLOR (Pale pink oval at injection site), PALPITATIONS (Heart was thumping), RASH (Swollen rash), VACCINATION SITE PRURITUS (Itchy at injection site/had an itchy), VACCINATION SITE SWELLING (Swelling at injection site), VACCINATION SITE PAIN (Injection arm soreness), FATIGUE (Fatigue), HEADACHE (Headache) and VACCINATION SITE PAIN (Stinging and burning at injection site) outcome was unknown and ERYTHEMA (Red dots) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Mar-2021, Heart rate: high (High) heart was beating very fast.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment was given with Petroleum Jelly.   This case was linked to MOD-2021-051047, MOD-2021-269406 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow up received contains updated  events, outcome, treatment and dose 2 information
No adverse reactions noted. Resident is on hospice for end of life care for terminal diagnosis cerebral atherosclerosis. Experiencing respiratory distress 2/10/2021 r/t to hospice prognosis.
about one half hour after shot my lips started to tingle. Lasted about 15 minutes. second day normal sore arm and very tired--slept most of the day. third day incredible pains all over my body--increasing fatigue. days four through six, pains increased, trouble walking, fatigue continued, brain fog started. Day seven pain went away, fatigued lightened up somewhat, could get out of bed, brain fog continued.  Through the rest of April through May, unable to concentrate, very fatigued. On August 30, woke up and suddenly able to concentrate and not fatigued. I have continued to be fine since.
Sudden cardiac death.  CPR was started within three minutes. Firefighters took over CPR and shocked me with an AED three times.   During the CPR, I sustained several broken ribs.  I was taken to Medical Center where I stayed for three nights and four days.  I had a heart catheterization which came back with no blockages.  I had an ultrasound of my carotid arteries which came back with no blockages.  I had an echocardiogram of my heart which was fine.   I had a defibrillator implanted in my left chest.  I am now trying to recover from this trauma.
Initial information received on 22-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a four years old male patient who received 0.5 ml FLUBLOK QIV lot QFAA1816, expiry date: 30-Jun-2019 via intramuscular route in the left arm. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to Inappropriate age at vaccine administration. It was reported that administered FLUBLOK to a four-year-old patient. No reaction reported. 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. Documents held by sender: none.
Approximately 4-6 minutes post vaccination patient started complaining of spasms radiating up and down spine, spasms created pain in spine, pt stated he felt that when his blood pumped he would feel the spinal spasm/pain.  Patient was in distress, discomfort, and had to sit down.  Breathing was accelerated.  Patient was given epipen 0.3mg for breathing issues (stated had a little trouble breathing and later stated breath felt warm).  Patient was then given oxygen by clinic next door to us.  02 was 93 right after epinephrine given, rose to 96-97 10-15 minutes later.  BP was 160/103 post epinephrine, lowered to 140/88 10-15 minutes later.  EMS arrived and evaluated patient approximately 18 minutes after reaction.  Patient felt normal and wanted to return home with his wife.  He was counseled by myself, EMS, and clinic's nurse.  He signed off with EMT approximately 35 minutes post event and then wife drove him home.  I checked on him at 12:46pm, approximately 2 hours after event and he feels normal, but is seeing doctor today.
Initial unsolicited report received from a consumer on 21 January 2017. This case involves an 81-year-old male patient who was vaccinated with a dose of FLU SHOT (batch number, expiry date, dose and dose in series were not reported) in an unknown site on an unknown date. Patient's medical history was reported as the patient got sick after had flu shot in 1992 and didn't take it again until 1998 also reported that the patient got sick again and took shot for pneumonia last winter because he has had pneumonia. Concomitant medications were not reported. On 21 January 2017, unspecified time following the vaccination, the patient got sick. Laboratory investigations was not reported. The patient had not received any corrective treatment. The outcome of the events was reported as unknown. List of documents held by sender: none.
Hurting in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Hurting in the injection site) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045a21a) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure. Concomitant products included INSULIN and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced VACCINATION SITE PAIN (Hurting in the injection site). On 22-Mar-2021, VACCINATION SITE PAIN (Hurting in the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications also included high blood pressure medication.  The patent did not receive any treatment medication.
sore arm; Muscle aches; Chills; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on (15Mar2021), this case now contains all required information to be considered valid.   This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer (patient) reported that a 73-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL9266/EL8982), via an unspecified route of administration in the left arm on an unspecified date at 9:45 am, as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose of BNT162b2 on an unspecified date and experienced sore arm. The patient experienced sore arm, muscle aches and chills on an unspecified date. The seriousness criteria of the events were reported as non-serious by the health authority. The outcome of the events was recovered on an unspecified date.  Follow-up attempts are completed. No further information is expected.