chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A report has been received from a Pharmacist concerning a 39 year old, female subject, who had been receiving FLUMIST (Intranasal). FLUMIST (INTRANASAL) started on 07-Jan-2014. The pharmacist reported that they accidentally gave a dose of expired FLUMIST which started on 07-Jan-2014. The outcome of the event of EXPIRED FLUMIST is unknown. The report was considered to be non-serious.
Became Faint, hypotensive and Diaphoretic. Right arm injection site clear. no redness or swelling. Initial BP 82/53 Pulse rate 147. Ate a granola bar and water. BP take again 124/80 Pulse rate 120. Patient became fatigued. Mom or dad picking up
Received first Pfizer Covid Vaccine on 4/30/21.  She states within 15 minutes of receiving the vaccine she experienced a weird sensation of her tongue, her heart was pounding, she felt flushed like her ears and head were on fire.  She reported it to the nurse observing her.  The nurse advised to wait another 15 minutes.  She reports that BP was 170/110 P 110. Her BP continued to rise and developed tightness in chest and dizziness and RRT was called and she was transported to the ED.  In ED she received Solumedrol, Benadryl, ASA 325mg and Pepcid.  EKG and cardiac enzymes were normal, BP decreased to 130/90 and she was discharge at 9pm. Next day, she experienced the same adverse reactions and was taken to ED. Patient had COVID Infection in January 2021.  Received first Pfizer Covid Vaccine on 4/30/21.  PMHx of HTN receiving treatment. She states within 15 minutes of receiving the vaccine she experienced a weird sensation of her tongue, her heart was pounding, she felt flushed like her ears and head were on fire.  She reported it to the nurse observing her.  The nurse advised to wait another 15 minutes.  She reports that BP was 170/110 P 110. She drank some water and performed deep breathing repeat BP 184/113 P 113.  Drank more water repeat BP 189/130 developed tightness in chest and dizziness and RRT was called and she was transported to the ED.  In ED received Solumedrol, Benadryl, ASA 325mg and Pepcid.  EKG and cardiac enzymes were normal, BP decreased to 130/90 and she was discharged home at 9PM.  The next day 5/1/21 awoke and felt fine however at 1PM experienced heart pounding, head on fire BP 150/104, 170/113, 189/130 took Benadryl, Pepcid and ASA; husband called 911 where she was taken to ED. Felt nauseated and was given Reglan.  CT head was normal, CXR normal and was discharged to home. The next day 5/2/21 again was fine in the morning but again at about 1PM started experiencing the same symptoms and made herself some cucumber juice and went to see her PCP who scheduled her to see a cardiologist on 5/3/21. Cardiac w/u included EKG, Echo, Holter monitor and stress test. All were reported normal except has not received results of Holter monitor yet. The next day she developed 2 lesions on the side of her tongue which she self treated with glycerin and Vitamin C. Her BP has since normalized to 130/80-90 which is her baseline and she has not had any further symptoms.
patient received only the diluent portion of Shingrix; patient received only the diluent portion of Shingrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 57-year-old male patient who received Herpes zoster (Shingrix) (batch number 7X5Y9, expiry date 22-NOV-2025) for prophylaxis.   On 31-OCT-2023, the patient received Shingrix. On 31-OCT-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: patient received only the diluent portion of Shingrix) and inappropriate dose of vaccine administered (Verbatim: patient received only the diluent portion of Shingrix). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 01-NOV-2023 The reporter reported that the patient received only the diluent portion of Shingrix. The reporter gave by error Shingrix diluent portion only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Extreme pain (unable to lift arm up), felt like pins/needles with light touch, unable to get comfortable in bed (called for ok to take ibuprofen; pharmacist said ok); next day arm was red, inflamed (huge welt on upper area); told to take Benedryl.. didn't have so they said to take the Loradadine (Claritin OTC); second day following saw Doctor... he was concerned and wanted me to report reaction here.
This spontaneous report was received from a registered nurse and refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 22-JUL-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N013865 with expiry date 31-OCT-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA006208:
ADMINISTERED VACCINE AFTER IT WAS RE-FROZEN AND THEN THAWED; INCORRECT PRODUCT STORAGE; OFF LABEL USE; This spontaneous report received from a health care professional concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A, and expiry: 11-APR-2022) dose was not reported, administered on JAN-2022 for prophylactic vaccination. No concomitant medications were reported.  On JAN-2022, the patient experienced administered vaccine after it was re-frozen and then thawed, incorrect product storage, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administered vaccine after it was re-frozen and then thawed, off label use and incorrect product storage was not reported. This report was non-serious.
3" redness and slight swelling at inject site.  Noticed approximately 19 hours after flu shot.  Minimal itching.
Vaccine induced myocarditis; This is a literature report.  A 36 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "hypertension" (ongoing); "smoking" (unspecified if ongoing); "prior alcohol use" (unspecified if ongoing); "chronic pancreatitis" (ongoing); "prior COVID-19 infection" (unspecified if ongoing); "median arcuate ligament syndrome (MALS)" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown", described as "Vaccine induced myocarditis". The patient underwent the following laboratory tests and procedures: brain natriuretic peptide (normal high range 100): 4734 pg/mL; catheterisation cardiac: showed normal coronary vasculature; chest x-ray: demonstrated a right pleural effusion; echocardiogram: revealed apical wall akinesis; electrocardiogram: showed a nonspecific st abnormality; epstein-barr virus infection: negative; hiv test: negative; magnetic resonance imaging heart: late gadolinium enhancement (lge) in the basal, notes: anterolateral, mid-anterior and midanterolateral walls; physical examination: rales, abdominal distention and pitting edema; sars-cov-2 test: negative; toxicologic test: negative; troponin (normal high range 17): 19222 ng/L. Therapeutic measures were taken as a result of myocarditis.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Vaccine induced myocarditis and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
1:28: BP: 168/99, HR: 117, O2:98%, felt different 1:30: Complaint of throat tightning, BP: 169/99; HR: 110, O2:98%, Med team alerted 1:34: Benadryl 25 mg, IM to right thigh 1:35: BP: 150/88, HR: 100, O2: 97% 1:40: MD report symptoms throat tighning after vaccine, no rash, no hives, talking fine, no change in voice, symptoms mild, no swelling of tongue, lips, or pharynx, pt refused epinephrine, improved over a few mins. Plan send to ED for continued observation; transferred at 1:43
Swelling, itching at injection site 7 days after receiving vaccination. Rash developing and spreading downward about 7 inches from injection site. Experienced pain and itching. Used ice packs, Benadryl and Tylenol. Slowly improving after 8 days  (15 days after receiving vaccine)
15OCT91 12noon mom phoned health unit reporting pt had seizure p/receiving DTP; seen by MD & recommends peds DT for future inject;
Administered today from a vial that was punctured more than 12 hours ago; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered today from a vial that was punctured more than 12 hours ago) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 088D21A and 051C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered today from a vial that was punctured more than 12 hours ago). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered today from a vial that was punctured more than 12 hours ago) had resolved.            No concomitant medications were reported. No treatment information was reported.
Throat/tongue swelling. Patient lost use of tongue and it was possibly swollen. Occurred 30 min after received flu shot. Rx'd solumedrol, Benadryl, Pepcid. Per MD: this was an allergic reaction, not a true anaphylaxis.
Swollen in the joint in the hand of the harm that I received the shot . Painful swollen joints ....
difficult getting dressed and is unable to return to the sports that he enjoys; significant pain in the arm; loss of mobility; pain in joints, but it's related to my shoulder/searing joint pain; the pain was deep in the muscle and stabbing like; This spontaneous case was reported by a consumer and describes the occurrence of IMPAIRED WORK ABILITY (difficult getting dressed and is unable to return to the sports that he enjoys), PAIN IN EXTREMITY (significant pain in the arm), MOBILITY DECREASED (loss of mobility), ARTHRALGIA (pain in joints, but it's related to my shoulder/searing joint pain) and MYALGIA (the pain was deep in the muscle and stabbing like) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 an unknown date, the patient experienced IMPAIRED WORK ABILITY (difficult getting dressed and is unable to return to the sports that he enjoys), PAIN IN EXTREMITY (significant pain in the arm), MOBILITY DECREASED (loss of mobility), ARTHRALGIA (pain in joints, but it's related to my shoulder/searing joint pain) and MYALGIA (the pain was deep in the muscle and stabbing like). At the time of the report, IMPAIRED WORK ABILITY (difficult getting dressed and is unable to return to the sports that he enjoys), PAIN IN EXTREMITY (significant pain in the arm), MOBILITY DECREASED (loss of mobility), ARTHRALGIA (pain in joints, but it's related to my shoulder/searing joint pain) and MYALGIA (the pain was deep in the muscle and stabbing like) outcome was unknown.            No concomitant medication provided. No treatment medication provided.   This case was linked to MOD-2021-101905 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Reporters contact details were updated On 07-Jun-2021: New Events were added On 21-Jun-2021: FU email was added
Approx 12 hours after the shot I got extremely cold and couldn?t warm up.  I was feeling fine when I woke at 6am.  My hands and feet were very cold to the touch.  I?ve had a slight cough since but I think it?s fall allergies.
This spontaneous case was reported by a medical assistant and describes the occurrence of INCORRECT DOSE ADMINISTERED (Pediatric patient of age 2 year 11 months old received first dose 0.25ml from Red Cap adult vial) in a 2-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014B22A) for COVID-19 prophylaxis. No Medical History information was reported. On 15-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 15-Jul-2022, the patient experienced INCORRECT DOSE ADMINISTERED (Pediatric patient of age 2 year 11 months old received first dose 0.25ml from Red Cap adult vial). At the time of the report, INCORRECT DOSE ADMINISTERED (Pediatric patient of age 2 year 11 months old received first dose 0.25ml from Red Cap adult vial) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient's age reported as 2 year 11 months old. No concomitant medications were reported. No treatment details were reported. It was reported that the patient received Moderna COVID-19 Vaccine dose of 0.25 ml from a vial with red cap and a label with light blue border with order number NDC: 80777-273-10. Reporter already notified the health department.
Approximately 4 hours after injection I experience an increased temperature of 99.5 and a headache, 12 hours later my fever increased to 103.5 and I began experiencing severe body aches. My fever remained at 103.5 and the body aches remained for 72 hours after injection. My fever was brought down only to 102.5 with Tylenol.
I was dizzy and I checked my bp and it was 70/40 i stopped talking my bp meds, drank water and my Bp came back up and I was fine. About a week later, i was short of breath. I called my asthma dr who ordered steroids. That did not make a difference. I never really got better. I figured the vaccine triggered my asthma. In march, I felt like i was going to pass out as I was walking into work. I went to work and was short of breath the whole night I called my doctor, I kept taking albuterol and steroid thinking it was asthma related .I worked that Sunday and went to the Dr on Wednesday who sent me to the hospital. I've been on anti coagulants since then. They thought it was a female cancer, or clotting problem. I have never taken birth control in my life so i had no participating factors. There are a few labs that cannot be done until after I am off of anticoagulants. These clots are completely unexplained and I have changed nothing aside from receiving the COVID vaccine.
pt recvd vax & 1-2 hrs post inject exp rash on chest & stomach & became weak, dizzy, nausea, syncope; 1wk later yellow color & paresthesia in back;
Headache, Arthralgia, Fever, SkinRash, Rash, Diarrhea, HYPERtension, HYPOtension, Tachycardia Narrative: Employee was treated in ER for ChestPain, rash, and fluctuating blood pressure given medication in ER and put on Predisone taper at discharge from ER
Very swollen lymph nodes under right arm, axillary (armpit) area, Pain in right arm and underarm.
minor sore arm, tired, chill, slight fever, nausea, muscle pain - this latest about 6 hours only.  8 AM - 2 PM.
sore arm; This is a spontaneous report from a contactable pharmacist. A male patient (physician) of an unspecified age received the bnt162b2 (BNT162B2; also reported as Pfizer-BioNTech COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced sore arm (non-serious).  The clinical outcome of the event was unknown.  No follow-up attempts are possible; information about batch/lot number cannot be obtained.
Wife received "wonderful news, chemotherapy, responded well.  Lung Cancer.; This is a spontaneous report from a contactable other hcp.    A 60-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown single for an unspecified indication. Medical history included Guillain-Barre syndrome, Lung Cancer. The patient's concomitant medications were not reported. It was reported that, the patient experienced wife received "wonderful news, chemotherapy, responded well lung cancer on an unspecified date .The Outcome of event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained. No further information is expected.
COVID 19 positive; COVID 19 positive; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Mar2021 as dose 1, single (Lot number: EN6207), on 06Apr2021 as dose 2, single (Lot number: EW0150), in right arm, on 02Dec2021 as dose 3 (booster), single (Lot number: 552590), in left arm and on 19May2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 63 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: COVID-19 (medically significant) with onset 02Oct2022, outcome "not recovered", described as "COVID 19 positive"; VACCINATION FAILURE (medically significant) with onset 02Oct2022, outcome "not recovered", described as "COVID 19 positive ". The patient underwent the following laboratory tests and procedures: Body temperature: (10Oct2022) 101, notes: fever of 101; SARS-CoV-2 test: (02Oct2022) Positive; (08Oct2022) Negative; (10Oct2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient was COVID 19 positive on 02Oct2022. She took Paxlovid for 5 days as directed. She then tested negative on 08Oct2022 and felt great. On 10Oct2022, she felt really sick again with a fever of 101 and tested positive.
numbness in her arms and legs; blood pressure is spiking; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness in her arms and legs) and HYPERTENSION (blood pressure is spiking) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20a) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (numbness in her arms and legs) and HYPERTENSION (blood pressure is spiking). At the time of the report, HYPOAESTHESIA (numbness in her arms and legs) and HYPERTENSION (blood pressure is spiking) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication use was not provided by the reporter.  Treatment information was not provided.
pt broke out in afternoon p/vax @ 9AM; hives on & off x 24-48 hrs scattered all over body;
Chronic soreness and feeling of diminished arm strength, more in left arm than right, since the vaccines were received. Intermittent cramps in biceps muscles, more left arm than right.
I received the vaccine yesterday 1/6/21.  Today, 1/7/21, I went for my walk this morning and felt off balance/swayed to the right a bit at one point. I don't think lightheadedness precipitated this, but it unnerved me.  I steadied myself and finished the walk without a problem. I checked and surface/pavement was uneven. My temp is 97.5 and I feel fine now but am just a little nervous that is a possible reaction to the vaccine. I had a reaction to the second dose of the hepatitis B vaccine 10 yrs ago, I fainted in early morning hours after getting up to go to bathroom.  I had received the second dose at about 11:30a the day before, and developed flu like symptoms by afternoon with a fever and ended up dehydrated which I think contributed to my fainting at about 3a when I got up to void.  I had a concussion and was treated with IV fluids at the local ED.
Child was give Novartis product H1N1 for 4y of age and older-prefilled syringe. Error noted when entering vaccine in the state registry immunization. Follow-up: No adverse event noted. Novartis advised us to file VAERS.
Severe joint pain in toes; Numbness of feet; swelling of the foot and ankle both feet are affected the left foot is the worst; swelling of the foot and ankle both feet are affected the left foot is the worst; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 23Mar2021 at 09:30 (at the age of 73-year-old) as single dose for COVID-19 immunisation. Medical history included coronary heart disease. The patient received unspecified medication within two weeks, Prior to vaccination. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccination within 4 weeks prior to the COVID vaccine. On 26Mar2021 at 15:45, the patient experienced severe joint pain in toes, numbness of feet and swelling of the foot and ankle both feet were affected the left foot was the worst. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported event. The clinical outcome of the events severe joint pain in toes, numbness of feet, swelling of the foot and ankle both feet are affected the left foot is the worst were not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient given Pfizer pediatric COVID-19 vaccine without dilution. No adverse effects observed in-store. Messages left for primary care physician and mother of child to contact the pharmacy. Pfizer was contacted and error reported. At this time, no specific steps advised other than to take supportive care for any local/systemic effects that may occur. They did not recommend repeating the dose. The second dose may be administered at the normal interval of 21 days later. Any judgment to not give the second dose must be evaluated on a case-by-case basis.