chrisvoncsefalvay/vaers-outcomes huggingface dataset:
respiratory illnesses; Patient has an immune disorder for which her immunologist wants her to have the Fluzone High-Dose instead of a vaccine indicated for her age/ recommends Fluzone High Dose and not FluAd; Patient has an immune disorder for which her immunologist wants her to have the Fluzone High-Dose instead of a vaccine indicated for her age/ recommends Fluzone High Dose and not FluAd; Initial information regarding an unsolicited valid non-serious case was received from consumer/non-health care professional via Medical Information (Reference number- 00757759) and transmitted to Sanofi on 07-Sep-2021.  This case involves a 63-year-old female patient who experienced respiratory illnesses, patient has an immune disorder for which her immunologist wants her to have the INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] instead of a vaccine indicated for her age/ recommends fluzone high dose and not fluad [Off label use and overdose].  The patient medical history included immune disorder (NOS) (not otherwise specified) and respiratory disorder NOS.  The patient medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot number and expiry date not reported] via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious respiratory illnesses (respiratory disorder) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was a case of actual medication error due to off label use in unapproved age group and overdose [Latency: on the same day].   Caller stated that she was immune compromised and has to get the vaccine. Since in her 40s, she had received high-dose Fluzone as prescribed by her immunologist. She had an immune disorder for which her immunologist wants her to have the Fluzone High-Dose instead of a vaccine indicated for her age. Her doctor specifically recommends Fluzone High Dose and not FluAd. She gets a lot of respiratory illnesses in general. She says she must be vaccinated for the flu in September, or else she would get a bad flu in October.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment for the events.  At time of reporting, the outcome was unknown for the events.  There will be no information available on the batch number for this case.
Pt is 5 years old and was given the 5-11 year old (orange cap) monovalent covid 19 vaccine, The vaccine was not diluted at administration so pt received 0.2ML of the vaccine with no dilution
Pt. called clinic today at 8:22am to report overnight fever and chills, as well as neck, left shoulder and left arm stiffness and pain at the injection site (left deltoid).   Pt. advised that she may alternate acetaminophen with ibuprofen for fever/pain  relief as well as heat/ice to help with muscle stiffness and pain.  Clinic will call patient on Monday to re-evaluate the condition of the patient.
rash is itching; rash is burning; rash on her chest/rash on her belly; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (rash is itching), SKIN BURNING SENSATION (rash is burning) and RASH (rash on her chest/rash on her belly) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (rash is itching), SKIN BURNING SENSATION (rash is burning) and RASH (rash on her chest/rash on her belly). At the time of the report, RASH PRURITIC (rash is itching), SKIN BURNING SENSATION (rash is burning) and RASH (rash on her chest/rash on her belly) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Woke with fever. Developed headache, severe tiredness and body aches by morning. Fever waned in afternoon. Headache remained (dull throb in skull) throughout day.
Pt's arm became swollen. Pt called pharmacy & was told to go to the emergency room. She was given a prescription for a GLUCAGEN 1mg hypokit & Cephalexin 500.
Patient received a second shot earlier than normal; This spontaneous case was reported by a medical assistant and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received a second shot earlier than normal) in a 32-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 033K21-2A and 068H21A) for COVID-19 vaccination.     Patient had no past medical history.    On 22-Mar-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 14-Apr-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2022,  after starting mRNA-1273 (Spikevax), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received a second shot earlier than normal). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received a second shot earlier than normal) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. Patient had no side effects. No treatment information was provided.
within 6 hours experienced severe chills and covid-like symptoms, she also tested positive for COVID-19; within 6 hours experienced severe chills and covid-like symptoms, she also tested positive for COVID-19; This is a spontaneous report from a contactable nurse. A 30-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration in left arm on 04Jan2021 11:30 at a single dose for COVID-19 vaccination. Medical history included allergies to Sulfa diagnosed in 2008, Allergies to Strawberries diagnosed when she was very young, Diamox allergy diagnosed in 2008, dyslexic, and Obesity but never been treated. Concomitant medication included levothyroxine (LEVOTHYROXINE), ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS), zinc (ZINC), nd cetirizine hydrochloride (ZYRTEC). The patient previously took diamox [acetazolamide] and experienced drug hypersensitivity.  Patient received first dose Monday, 04Jan2021, then she experienced severe chills and Covid like symptoms. Apparently, she tested positive for COVID 19. She ws not sure if it was a false positive or if she actually has COVID, but was concerned because her husband has cancer and was immunocompromised. Literally, she got the vaccine because her OB/GYN told her she needs to get it as soon as possible. She did blood work and she tested negative for pregnancy. There was no prescriber as it was given as part of her work. Fifteen minutes after receiving the vaccine, she had the worst headache she has ever had in her life. Six hours after that, she had such bad chills. That night, it worsened and it got better every hour when she took something. She said her congestion was still present. She stated she took Tylenol and hour later and it subsided. The outcome of the events was not recovered. The patient underwent laboratory date including negative antibodies on an unknown date, blood work on Mar2020 with unknown result, then on 05Jan2020 tested positive to COVID 19 by saliva test at 09:15 and nasal test at 11:30  Information about Lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded.  The case will be reassessed if additional information becomes available
Patient reported the evevning after the flu shot, her deltoid muscle was hard, warm and shore. She also developed a rash before the site of injection, about 2 inches in diameter. Today (6 days after injection) she came by to report these symptoms. Symptoms are getting better but she still experiences some soreness on her arm.
The symptoms started on the day following the vax and persisted for two days. Abdominal cramping, loss of appetite, low grade fever of 99-100 degrees, aching joints, tiredness, soreness of injection site. Symptoms began 3 hours post vax.
Chills, fever, body aches, headache, fatigue, insomnia, painful skin, pain at the injection site. Everything started at 9pm that night, was significantly improved by 8am the next day, but fatigue and headache persisted. All resolved by 2-14-2021.
Patient  was sent from urgent care to the emergency department due to hypoxia.  Chest x-ray indicating pneumonia.  He was complaining of generalized body ache mostly on the right side.His COVID-19 test is negative on 12/30/21. Then positive on 1/6/22.  He was treated with dexamethasone and  Remdesivir
Headache and fever started  about 7 hours after vaccination. He took 200 mg Ibuprofen .  He had difficulty sleeping . Had a fever of 100.2 at 7am.
Administered dose of 0.2 ml. Vaccine leaked out of faulty syringe. Less than required dose administered. As per CDC guidelines, repeat dose recommended. Parent refused. Parent stated she would consult child immunologist.
Body aches; Pain on left side from upper lower back all the way to top of head that included injection site, under armpit, left upper shoulder neck radiating to lower mid back; Pain on left side from upper lower back all the way to top of head that included injection site, under armpit, left upper shoulder neck radiating to lower mid back; swelling under armpit; swelling on left upper chest; This is a spontaneous report from a contactable nurse. A 44-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported), dose 2 via an unspecified route of administration on 30Jul2021 as dose 2, single for COVID-19 immunization (at the age of 44-year-old). Medical history included migraine, ongoing asthma, recently vitamin d deficiency and known allergies. Concomitant medication included ibuprofen. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration, administered in left arm on 09Jul2021 as dose 1, single for COVID-19 immunization (at the age of 44-year-old) which led to nausea, body aches, heat sensation on chest, mouth blisters, fever, sore throat, headaches and migraines. No other vaccine in four weeks. The patient did not had COVID prior vaccination. On an unspecified date in 2021, the patient experienced body aches swelling under armpit, swelling on left upper chest, pain on left side from upper lower back all the way to top of head that included injection site, under armpit, left upper shoulder neck radiating to lower mid back. Seriousness of the events reported as non serious. On 09Jul2021, the patient underwent lab tests and procedures which included fever: unknown results and on 20Jul2021, nasal swab: negative. The patient was treated with oxycodone, toradol, muscle relaxer and otc ibuprop as a therapeutic measure of body aches swelling under armpit, swelling on left upper chest, pain on left side from upper lower back all the way to top of head that included injection site, under armpit, left upper shoulder neck radiating to lower mid back. On an unspecified date in 2021, the patient recovered with sequelae from body aches, swelling under armpit, swelling on left upper chest. The outcome of the other events was not recovered.  Follow-up attempts completed. No further information is expected.
This spontaneous report as received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 03-MAY-2012, patient received improperly stored VARIVAX dose 2, from batch/lot# 1273AA (expiry date, dose units, route and anatomical location were not specified) (incorrect product storage). Concomitant medication were not reported. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of the several reports received from the same reporter. Additional information has been requested.
Patients wife called 12/06/2016 and said the flu shot caused her husbands muscle in his left arm to hurt and that he was going to the doctor on 12/7/16. I called patient's wife to check on patient on 12/09/2016 and patient's wife said the doctor did not say anything but she knows it is from the flu shot.
A non-serious spontaneous report of inadvertent administration of expired H1N1 was received from a registered nurse/health professional concerning a four-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The original expiration date was 08-Apr-2010, which was reassigned to 29-Mar-2010. On 31-Mar-2010, the patient received the second dose of H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable and the event was considered to be resolved.
Rash and itch through out th whole body,  especially back. Patient contacted primary care physician today, 12/20/2019. Patient is taking Benadryl as needed. Patien says she sometime developes similar rashes, so she is not sure entirely sure this rash is related to vaccination.
Severe cough, breathlessness, slight fever(99.3); coughed for over 2 1/2 hours. Unable to breathe properly or stop coughing.
increased AFib episodes; joint ache esp to left knee with pain; Headache; This is a spontaneous report from a contactable nurse (patient).  A 54-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), via an unspecified route of administration at arm left on 28Jan2021 at 11:00 (at the age of 54-year-old) at single dose for COVID-19 immunisation. The patient was not pregnant.  Medical history included atrial fibrillation (AFib), depression, aortic stenosis and allergy to sulfa, all from an unknown date and unknown if ongoing.  Concomitant medication included losartan, HCTZ, sertraline hydrochloride (ZOLOFT), vitamin D3, magnesium and cyanocobalamin (VITAMIN B12).  The patient previously took LEVOQUIN and prednisone and experienced allergies. On 02Feb2021 at 08:00, the patient experienced increased AFib episodes, joint ache esp. to left knee with pain and headache.  The patient underwent lab tests and procedures which included SARS-COV-2 (nasal swab) test: negative on 22Feb2021. Therapeutic measures were taken as a result of the events and included acupuncture and the events required physician office visit. The patient outcome of the event was not recovered.; Sender's Comments: There is not a reasonable possibility that event atrial fibrillation is related to BNT162B2.  The event only occurred 4 days after vaccination.  And the patient had underlying atrial fibrillation, which is considered the most likely cause of the reported event.   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.
Pt had a syncopal event a few minutes after receiving his COVID-19 Moderna vaccine.  He was seated in a chair for a 15 minute observation period. He fell off the chair onto his side. He regained consciousness within about 10 seconds of falling off the chair. He was placed in a supine position with legs elevated. He was given water.  He denied any pain associated with fall. Denied any symptoms of itching, swelling, cardiac, or GI complaints. He was alert and oriented x4 with color and temperature within normal limits.  After 10 minutes lying down, he was assisted into a chair for further observation. He denied any further symptoms and was discharged after an additional 15 minute observation. He was advised to seek emergent care if he experienced any worsening symptoms.
LEFT ARM HAS LARGE PATCHY AREAS OF REDNESS AND SOME SWELLING, AREAS WARM TO TOUCH AND TENDER TO TOUCH.
Patient is a 71-year-old female with PMH of type 2 diabetes, hypertension, hyperlipidemia, cataracts, glaucoma who was transferred from Medical Center as a stroke code after she presented there for right-sided weakness, facial droop and visual changes. Patient was given TPA in the past she was within window and she was then transferred here for further management.  Patient's symptoms continue to resolve.  She was admitted in the ICU and managed by neuro critical care and neurology.  Further imaging including CTA head and neck, MRI brain did not reveal any stroke.  An assessment of small vessel disease was made which likely resolved after TPA was given.  Patient was assessed by PMR and PT/OT and deemed safe to go home with family care and no restrictions.  Echo, telemetry and EKG showed no signs of cardiac involvement.  Patient was started Plavix x21 days and chronic baby aspirin.  She was also started on Crestor 20 mg daily.  Patient is to follow-up with neurology in 3 months as she got TPA.  She will also follow-up with her PCP on discharge.
Pt is fully vaccinated as on 1/13/2021 with Pfizer and contracted COVID, tested positive on 9/17/2021
This spontaneous report was received from a healthcare worker refers to a patient of unknown demographics. On 25-SEP-2014 the patient was vaccinated with PROQUAD (Merck) (lot # K005646 with the expiry date of 17-OCT-2015). Approximately in the year 2014 PROQUAD (Merck), which was involved in supported temperature excursion. No concomitant therapy was reported. No adverse effects were reported. No Product Quality Complaint (PQC) was filed. This is one of the several reports received from the same reporter. Additional information has been requested.
No additional AEs were reported; improperly stored vaccine was adminitrated; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 24-MAR-2022, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) (strength and route were not reported; lot # u026217 was evaluated and changed to the valid lot # U026217, expiration date: 02-NOV-2023) 1 dose for prophylaxis (product storage error).   It was reported that the suspect vaccine was exposed to a temperature of 34.3 Fahrenheit (F) for a time frame of 55 minutes. There were no previous temperature excursions.   No additional adverse event (AE) information was provided.   This is one of the multiple cases reported by the same reporter.; Sender's Comments:  US-009507513-2204USA001814:
PT HAS INJECTION SITE REACTION INVOLVING REDNESS AT SITE APPROXIMATELY 2 INCHES IN DIAMETER, SWELLING AT SITE, HOT AND TENDER TO TOUCH.  PT DOES NOT OTHERWISE FEEL ILL.
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypertension-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium
Mild flu-like feeling, very tired, no appetite, only wanted to rest and sleep. I check my blood pressure often and during the day after my shot my pressure was high all day, at one point was 160 over 90. As of today, the 17th of March, my pressure has gone down to normal. My symptoms lasted just over 30 hours.
Tired; This is a spontaneous report from a contactable consumer (patient). An 86-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date, as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) for covid-19 immunisation and she felt wooziness after the first dose that caused her to wait about an hour before and it was safe to drive herself home. On an unknown date, the patient experienced tired after both doses. The outcome of the event was unknown.  No follow-up attempts are needed. No further information expected.
Atrial fibrillation; This is a spontaneous report from a contactable consumer (reported for herself). A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EN5318; expiry date: not known), via an unspecified route of administration in the left arm on 01Feb2021 10:45 at single dose for COVID-19 immunization. Medical history included deep vein thrombosis (DVT) and allergies to sulfa drugs. The patient's concomitant medications were not reported. The patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. The patient previously took amoxicillin, clavulanate potassium (AUGMENTIN) and experienced allergies. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient experienced atrial fibrillation on 01Feb2021 17:45. No treatment received for this event. The outcome of the event was recovered on an unspecified date in Feb2021.
Day one-just some arm pain at injection sight. Day two at 8 AM-small raised rash appearing on right size of chest, severe fatigue, mild headache, muscle and joint pain (moderate). Day 3 s/p vaccine: rash has spread to left side of chest. Almost looks like petechiae bruising with raised rash, small in size. Total diameter of total rash is about 7 inches across chest. Does not itch or hurt. Aches and pains mostly gone. Headache gone, mild fatigue.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: Shortly after vaccine was administered, patient lost consciousness