chrisvoncsefalvay/vaers-outcomes huggingface dataset:
nose kept running like a faucet; skin peeled off under her feet; very sick for 3 days; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (Patient's Mother) reported for a 44-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced nose kept running like a faucet, skin peeled off under her feet, very sick for 3 days. It was reported that daughter just took both doses of the Pfizer-BioNTech COVID-19 Vaccine, a young girl with no medical issues. After the first dose, Daughter experienced severe reactions. After the second dose, Daughter had "running nose, like a cold", "skin on feet peeled" but she didn't get sick. Caller asked if these are possible side effects. The outcomes of events were unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
rheumatoid arthritis involving small joints of hands;positive rheumatoid factor 1st sx MAR95 following 1st hep B vax;
Patient states she had pretty noticeable arm swelling with redness and pain. Breathing was okay and swelling started to go down after 24 hours. Told patient to keep it under her radar and to give us a call if it gets worse. If breathing is affected, to go to the ER
A non-serious spontaneous report of itchy rash and hives rash on trunk, arms and legs has been received from a registered nurse concerning a 12-years-old male, subsequent to H1N1, Intranasal. The patient's medical history and concomitant medications were not provided. On 19-Oct-2009, the patient received H1N1. Within hours of vaccination, the patient developed an itchy rash and hives on his trunk, arms, and legs. The events have improved.
HPI: This is 69 years old man with extensive cardiac history including coronary disease status post CABG in 1995, stable from that standpoint with recent negative stress test.  The patient also has a history of A. fib for which he is on Xarelto.  He was on Lopressor for years and complained to his primary care provider that he had a rectal dysfunction so this was discontinued on Thursday and he was started on Norvasc.  He went to a bar to wash therapy with friends and after he had to severe he started feeling dizzy heaviness in the head and blurry vision.  He denies having any chest pain, shortness of breath, headache, focal weakness numbness tingling.  He has had no palpitation.  He got concerned so he came to the emergency room.  He had no symptoms in the ER. EKG showed atrial fibrillation with nonspecific ST-T change.  Chest x-ray showed no acute intracranial abnormality.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Pertinent medical history, drug reactions or allergies were not reported. On 28-SEP-2014 the patient was vaccinated with an expired dose of M-M-R II, lot # H014988, expiration date 08-AUG-2014, (dose, dose number, route and anatomical location were unspecified). Dose supported. No concomitant therapies were reported. No adverse experience reported. The outcome of the events was unknown. Additional information has been requested.
I had  minor reactions to the first intramuscular dose of this vaccine but the second intradermal dose produced a quarter sized dark red solid welt plus around a 6 inch radius of red skin, all extremely painful to the touch.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 31-MAY-2017, the patient was vaccinated with expired ZOSTAVAX (lot # L046896, expiration date 23-FEB-2017) for prophylaxis (dose and route of administration were not reported). The product did not have any temperature excursions prior to administration. No adverse symptoms reported. No product quality complaint was involved. Additional information has been requested.
INFANT DECEASED 16 HRS. POST IMMUNIZATION ADMINISTRATION.  NO ADVERSE SIGNS OR SYMPTOMS DESCRIBED BY MOTHER.  AUTOPSY DID NOT IDENTIFY ANY SIGNS OF ADVERSE REACTION.  12/26/2007 Vax record and MR received from PCP. Vax record as reported on VAERS report.   1/11/2008 Autopsy Report received with Child Fatality Investigation Report.  COD: Sudden Unexpected Death in Infancy. Infant had been sleeping on sofa with mother.  Mother felt child was warm and gave Tylenol.  Respiratory Distress was noted by mom.  EMS notified and CPR initiated however child was pronounced dead upon arrival at medical center. Unsafe sleeping conditions documented. Distinction between SIDS and subtle forms of asphyxia could not be made by autopsy alone.
Patient started having involuntary jerky movements started 20 minutes after injection started in shoulders & arms. Involuntary movements. Next day saw Legs suddenly Abduct/Flex at the hips both sides. Referred to Neurology. Neurologist feels the tics are functional-involuntary but NOT related to an underlying Neurological condition. Theese movements have persisited.
Two weeks after first Moderna dose,  a big flare up of my well controlled RA. I haven?t had a flare up of this magnitude and length in over a decade.
Patient broke out into hives after vaccination. Per mother the next morning patient had swollen face and urticaria.
Complained of itching on the left hand above thumb 1/2 hr after Flu inj. No complaint of SOB, no CP, no dyspnea, no hives, no difficulty swallowing BP 220/100. 11:15 called squad. 11:35 Taken via ambulance to hospital. Pt states, "I am the AHS man and we are having a major conversion today. I am selling and buying a house."
This spontaneous report was received from a healthcare worker refers to unspecified number of patients of unknown age and gender. No medical history or concomitant medications were reported. On an unknown date the patients were vaccinated with improperly stored doses of VAQTA (lot number-L007559, expiry date-01-JUN-2017 and lot number-L028666, expiry date-04-NOV-2016, dosing regimen unknown). No adverse events were reported. No laboratory tests were reported. No product quality complaint (PQC) was involved. The outcome of the events was unknown. The reporter considered events to be not related to VAQTA. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Patient felt sick after she received her booster dose; Hurt all over; Felt like she had the flu; Every joint in her body hurt; Patient had a low grade temperature/patients temperature was 99 degrees Farenheight; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Patient felt sick after she received her booster dose), MYALGIA (Hurt all over), INFLUENZA (Felt like she had the flu), ARTHRALGIA (Every joint in her body hurt) and PYREXIA (Patient had a low grade temperature/patients temperature was 99 degrees Farenheight) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer vaccine and Pfizer vaccine (The patient received her primary series of vaccination as a Pfizer vaccine and reported no adverse reactions.). Past adverse reactions to the above products included No adverse event with Pfizer vaccine; and No adverse reaction with Pfizer vaccine.    On 08-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Patient felt sick after she received her booster dose), MYALGIA (Hurt all over), INFLUENZA (Felt like she had the flu), ARTHRALGIA (Every joint in her body hurt) and PYREXIA (Patient had a low grade temperature/patients temperature was 99 degrees Farenheight). At the time of the report, MALAISE (Patient felt sick after she received her booster dose), MYALGIA (Hurt all over), INFLUENZA (Felt like she had the flu), ARTHRALGIA (Every joint in her body hurt) and PYREXIA (Patient had a low grade temperature/patients temperature was 99 degrees Farenheight) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99 The patient had a low grade temperature. The patients temperature was 99 degrees Farenheight..         The patient received the booster dose in her left arm shoulder deltoid muscle. No concomitant medications were reported. There was no product complaint associated. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Feb-2022: Follow up includes no new information.
Right Sided Bell's Palsy; This is a spontaneous report from a contactable Other-HCP reporting for a patient. A 54-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Right on 05Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included Stargardt's Disease, Prediabetes, Low Testosterone, Chronic neck pain, and covid-19. Concomitant medication included testosterone (AXIRON). No other vaccine received in four weeks. The patient experienced right sided bell's palsy on 07Apr2021 06:00. The event resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of right sided bell's palsy included Prednisone. Outcome of the event was not recovered. No Covid tested post vaccination.  Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported Bell's palsy cannot be excluded based on a temporal relation. 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 RAs, Ethics Committees, and Investigators, as appropriate.
8/6/99 lt foot, started in toe is now aching w/walking, pain increases;aching there @ all times;
Pt states she took FLu and Pneumonia vaccine on 03/26/2022 and  she noticed the symptoms of nausea, vomiting with localized swelling and redness at the injection site on 03/27/2022
Pfizer-BioNTech COVID-19 Vaccine EUA  Severe nausea without vomiting and severe diarrhea
I've been sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced sickness. On an unknown date, the outcome of the sickness was not recovered/not resolved.   It was unknown if the reporter considered the sickness to be related to Shingrix.     Additional Information: GSK Receipt Date: 07-SEP-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The reporter reported that the patient received Shingrix vaccine. The reporter stated that after received Shingrix vaccine the patient had been sick from 4 days already. Follow-up would not possible as no contact details were available.
Myalgia chills, fatigue, sore arm Narrative:  After 2nd vaccine for COVID-19 experienced arm soreness, chills, fatigue and muscle aches. She had to leave work on 1/14 due to chills. Later on 1/14 her symptoms resolved.
Rash on chest, face and legs. Puffiness around eyelids. Went to urgent care for evaluation and treated with po Benadryl and Tylenol.
arm pain (injection site); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm pain (injection site)) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939904) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, the patient experienced VACCINATION SITE PAIN (arm pain (injection site)). At the time of the report, VACCINATION SITE PAIN (arm pain (injection site)) outcome was unknown.            Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Approximately 5 minutes after vaccination, GM brings patient back to clinic room states "patient has went limp".  Upon assessment, patient was limp, eyes open in fixed stare, unresponsive/listless.  Patient's heart rate 120, rr 40: no labored breathing.  After 5 minutes of monitoring, patient became attentive and alert.  Referred to pcp for assessment.
This spontaneous report was received from a Nurse refers to a female patient of unknown age. On 25-FEB-2014, the patient was vaccinated with the third dose of GARDASIL, 0.5 ml, intramuscular. The nurse reported that the patient vaccinated the first dose of GARDASIL on 20-SEP-2013 and second dose of GARDASIL on 17-DEC-2013. No adverse effect was reported. Additional information has been requested.
Unintended excessive dose- given 0.2mL ID rather than 0.1mL No current adverse reaction
Within 8 hours of the vaccination I experienced nausea and severe stomach cramping. The cramping turned into violent diarrhea  that  lasted for 2 days. During this time I had a fever and chills. I still am experiencing  some cramping but the diarrhea and chills have subsided. I have bouts of extreme tiredness that come for no reason.
One week of the vaccine, while having some coffee and cookies. About tens of consuming them, I felt like I was getting a cold and had to keep clearing my throat.  I told my wife I feel wired and she mentioned my right eye looked different.  In about two more minutes my right was swollen closed and speaking became difficult due to the swelling.  My wife drove me to Hospital and I received Epinephrine and Benadryl and fluids.
6.5 x 7.0cm induration at injection site, beginning approx 24 hrs. after injection. No systemic complaints.
Fever of 102, severe headache, severe body aches, severe chills, immense fatigue, enlarged lymph node on side of injection,  nausea, no appetite.  All started roughly 6 hours after administration of vaccine.  Site reaction- about 24 hours post vaccine, the site is hot, extremely painful red, hard, and swollen, an area about the size of a softball, lasting until day 5 post vaccine.
Patient noted that she fainted once before for a vaccine due to fear of needles. Explained we could watch for 15 mins post vaccination. Patient administered vaccine at 1:15 and immediately after, she slumped into the chair, convulsed, eyes pupils fully dilated for 30 secs and was resumed consciousness 60-90 secs later. Patients mom aware, patient was able to remain in vaccine room for observation for 20 mins for full recovery. Recommended that patient be seen by provider asap for further evaluation. Mom agreed.
headache; fever; fatigue; mucus; This is a spontaneous report from a contactable other HCP. This nurse(patient) reported for a 18-year-old female consumer (reporter daughter) that:   A 18-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Expiry date: Unknown), via an unspecified route of administration on 22Jul2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Investigation assessment was not provided. On 28Jul2021 patient complaints of headache, fever, fatigue/ feeling tired and having mucus. The clinical outcome of the event was unknown.  Communication: The caller was provided with phone number of #, option 3, and hours of operation, prior to warm transfer to Agent INT-#  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 43-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE UNSTABLE ANGINA ANGINA, UNSPECIFIED 6/10/2022 -- RECURRENCE OF SAME SYMPTOMS
Information has been received from a physician concerning a 77 year old male with hypertension, hyperlipidemia and a history of cerebrovascular accident who on 16-OCT-2006 was vaccinated SC in the left arm with a first dose of Zostavax (Merck) (lot # 652965/0622F). On 03-DEC-2006, six weeks after vaccination the patient developed shingled over his face and scalp. Medical attention was sought. It was reported that the patient had no prodrome and minimum neuropathic pain. At the time of the report the patient was recovering but not well yet. No further information was provided. Additional has been requested.  This is in follow-up to report(s) previously submitted on 2/13/2007. Additional information from the physician indicated that on an unspecified date the patient recovered. It was reported that the patient had no neuralgia, either prodromal or post infection. The patient felt that the vaccine "made his shingles better" No further information was provided. Additional information is not expected.
MALFUNCTION OF VANTAGE POINT SYRINGE UPON INSERTION RESULTING IN LOSS OF VACCINE. PT RECD FPIZER 0.3 ML IN OTHER ARM.
About 5 minutes after receiving the shot, patient experienced itching and redness around the injection site as well as itching on the scalp. Patient immediately took 50 mg of BENADRYL and itching resolved in 10-15 minutes. Patient to continue with BENADRYL 50 mg every 4-6 hours and follow-up with PCP if necessary.
Drug ineffective; suspected COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:.  An 81-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose number unknown (booster), single (Batch/Lot number: unknown) subcutaneous for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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 "recovered"; SUSPECTED COVID-19 (medically significant), outcome "recovered". Clinical course: Consumer reported that her mother got COVID after three to four shots of Pfizer COVID vaccine. It was not serious and it resolved quickly.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
positive Covid-19 tests; positive Covid-19 tests; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 87-year-old female patient received BNT162b2 (BNT162B2), in Jan2021 as dose 1, single (Lot number: EL9262) and in Feb2021 as dose 2, single (Lot number: EL8266) at the age of 86 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), in Oct2021 as dose 3 (booster), single (Lot number: 301418A), in arm for covid-19 immunisation. The patient's relevant medical history included: "stable angina", start date: 2012 (unspecified if ongoing), notes: never had any reaction or anything from it in 20 years. The patient's concomitant medications were not reported. Vaccination history included: Flu shots, for Immunization, reaction(s): "arm gets a little sore after shots". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "positive Covid-19 tests". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course- Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): Had a flu shot, but she did not know when she got the flu shot in relation to the booster.   No follow-up attempts are needed. No further information is expected.
The first symptom was coughing. The second symptom was a sore throat. The third was lethargy, fever, and extreme tiredness. I also had congestion and nausea. I had body aches. The cough was persistent, and I couldn't sleep because of it. The symptoms lasted a full seven days. I received monoclonal antibodies. I also received benzonatate.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 18Apr2022 at 13:00 as dose 4 (booster), single (Lot number: FJ4989) at the age of 70 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Visteral, reaction(s): "Drug allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Our immunizing technician accidentally gave the 17 year old patient a moderna vaccine as her first dose without verifying with the pharmacist before giving the shot. Currently Moderna is only approved for adults age 18 years or older.