chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Anaphylactic reactions immediate; my blood pressure drop suddenly; airways narrow; blocking breathing/ trouble breathing; Constriction of the airways by my swollen tongue and throat; Constriction of the airways by my swollen tongue and throat; Constriction of the airways by my swollen tongue and throat; wheezing; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Apr2021 as dose 1, single (Lot number: ER8735) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Gerd" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: ANAPHYLACTIC REACTION (medically significant) with onset 18Apr2021, outcome "recovered with sequelae", described as "Anaphylactic reactions immediate"; SWOLLEN TONGUE (non-serious), THROAT TIGHTNESS (non-serious), PHARYNGEAL OEDEMA (non-serious) all with onset 18Apr2021, outcome "recovered with sequelae" and all described as "Constriction of the airways by my swollen tongue and throat"; SMALL AIRWAYS DISEASE (non-serious) with onset 18Apr2021, outcome "recovered with sequelae", described as "airways narrow"; DYSPNOEA (non-serious) with onset 18Apr2021, outcome "recovered with sequelae", described as "blocking breathing/ trouble breathing"; BLOOD PRESSURE DECREASED (non-serious) with onset 18Apr2021, outcome "recovered with sequelae", described as "my blood pressure drop suddenly"; WHEEZING (non-serious) with onset 18Apr2021, outcome "recovered with sequelae". The events "anaphylactic reactions immediate", "my blood pressure drop suddenly", "airways narrow", "blocking breathing/ trouble breathing", "constriction of the airways by my swollen tongue and throat" and "wheezing" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Apr2022) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of anaphylactic reaction, blood pressure decreased, small airways disease, dyspnoea, swollen tongue, throat tightness, pharyngeal oedema, wheezing.  Additional information: The patient was administered 2 injections of epinephrine and Benadryl and ambulance to the emergency room. Was in emergency room on monitors for several hours.
A month after receiving 3 dose I began having heart issues. Racing heart, pounding heart, missed beats, and other arrhythmias. (Symptoms seem to be worse when reclined) Occasional shortness of breath. Went to PCP in February and they did blood work, all returned normal and referred to my cardiologist. June 30th went to regularly scheduled cardiology appointment. Cardiologist performed halter monitor and EKG. CT calcium score ordered by cardiologist TBD.
Pt did NOT have adverse reaction to Covid 19 Biontech Pfizer injection. Pt was suppose to get Bivalent and was given a regular dose instead. Will report and also pt will be contacted to advise that Bivalent can still be given in 2 months from 9/26/22
Patient's mother brought patient in to receive a COVID-19 Pfizer vaccine on 08/31/2021.  The patient?s mother filled out a consent form on behalf of the patient and listed the date of birth and signed and consented on the official Health Department Pfizer-BioNTech consent form.  The nurse verified the name and date of birth with the patient and the patient?s mother.  Public Health guidelines were followed, and the parent received the up-to-date Pfizer-BioNTech EUA and the vaccine was administered.  In the patient?s 15-minute wait there were no adverse reactions. Three weeks later, on 09/21/2021 the mother once again filled out a consent form and stated her child's birthday. Upon entering the vaccine into the Immunization Information System it was discovered that the patient's true DOB was different and therefore this was an unauthorized vaccination.  The date of birth was then confirmed and verified in the System.  The Public Health Department Medical Director was notified.  In addition, the patient's parent/guardian was informed.
Approx 20 mins after shot, started itching/burning over arms, back, abdomen. Felt burning sensations through out body. Decreased by night time. Next morning right index finger started to burn and turn pink/red. Warm to touch. Burning and Tingling sensation continued to travel down finger to wrist to elbow to remaining fingers. Dr visit on 10/21/10. Course of steroids administered. Started at approx 05:30 PM on 10/21/10. Final outcome pending.
Information has been received from a Medical Assistant concerning her female baby whose mother was vaccinated with GARDASIL, a Pregnancy Registry product. The patient was born at 36 weeks gestation via vaginal delivery with a "birth mark on her lip" classified as a "hemangioma". The baby's health otherwise was good, no other problems encountered. The baby weighed in at 6 lbs, 10 oz. At the time of the report, the outcome of hemangioma was unknown. It was unknown if the patient sought medical attention. Follow up information has been received from a pediatrician reported that the haemangioma was 2 mm in size. The pediatrician stated that the haemangeioma will grow for the first year. The patient's haemangioma was under a dermatologist's observation (dermatologist's name or contact information was not reported). The mother's experience was previously reported in WAES#1009USA03287. Upon internal review, haemangioma was considered to be a congenital anomaly. Additional information has been requested.
It was reported that a female pt received a Fluzone UNSP vaccination on 11/1/99. Reportedly, that same day, the pt experienced a local reaction of stinging when receiving the shot and redness at the site, afterwards. Pt also stated, "I felt as if I had some swelling of the tongue but nothing that worried me. It has dissipated."
FLUZONE QUADRIVALENT age 6 month and older from a multidose vial  (FLU State) was administered to a 17 months child. QTY 0.5ml.
Patient was vaccinated pass the Beyond Use Date for 2 doses in the primary series of the vaccine. Patient has no symptoms. Patient has been contacted and arrangements have been made to have her re-vaccinated.
Pt recvd 3 doses of Engerix-B vax & it was determined that pt did not seroconvert; 4th dose of Engerix-B was administered;
I began having joint issues.  My fingers were locking up in closed position. My ankle joint, my elbow and my knee and jaw also began catching occasionally most predominately on the right side at the beginning then started on the left side about six months later it only lasted a short time then it resolved. I still have issues with my right ankle with loss of ROM and some joint pain.
Pulmonary embolisms that blocked off right lung and infiltrated left lung. Symptoms included severe shortness of breath and stabbing pain in right upper back.  CT scan performed during ER visit, resulting in overnight hospital stay.  Blood thinners (heparin and Lovenox) administered in the hospital, on 6 month course of Xarelto for continued treatment.  No other causes for clots found (not on birth control, non-smoker, no genetic/family history).
Neck swollen on left side; Sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Neck swollen on left side) and VACCINATION SITE PAIN (Sore left arm) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced SWELLING (Neck swollen on left side) and VACCINATION SITE PAIN (Sore left arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, SWELLING (Neck swollen on left side) and VACCINATION SITE PAIN (Sore left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.
This spontaneous report was received from a pharmacist referring to a 61-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 05-NOV-2016, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (lot number L034736, expiration date 09-DEC-2016; dosage and route of administration were not provided). No adverse effects were reported. The administered vaccine experienced a temperature excursion of 22F for 18 hours on an unspecified date. Data logger was not involved. The previous temperature excursion was 10F for 14 hours, 28F for 18 hours and 40F for 1 hour on an unspecified dates. A product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information is not available.; Sender's Comments: US-009507513-1610USA002328:
fell and broke his hip; fell and broke his hip; tested positive for COVID-19; This is a spontaneous report from a contactable consumer.  An 80-year-old male patient received his first dose of bnt162b2 (BNT162B2 also reported as Pfizer COVID-19 vaccine, lot EL1283, expiry date 30Apr2021), intramuscular in right arm on 22Jan2021 10:00 at SINGLE DOSE for Covid-19 immunisation. Medical history included ongoing Parkinson's disease diagnosed in Jan 2018 and the Neurologist said that the patient probably had it for 6-8 years; ongoing hypertension (its been years); had cardiac and thyroid disorder. The patient was on unspecified medication for his thyroid. The patient fell and broke his hip on 02Feb2021 08:30 and was hospitalized. It was reported that he will have a surgery. The patient underwent laboratory test Sars-cov-2 test: positive on 02Feb2021, weight: 170-175 lbs on unknown date. He also had an echocardiogram a couple of weeks ago (2021) because he was seeing a new heart doctor. The doctor did say that he had a mild leaky aorta and will continue just the medication he was on. He was scheduled to receive the second vaccine on 12Feb2021. The outcome of events was unknown.  No further details were provided or obtained.
Employee was being monitored post Covid19 vaccination. Approximately 10 minutes after vaccination employee had an allergic reaction and developed Hives all over her body and became itchy with hot flashes. Employee was given 50MG of Benadryl which was effective.
High Fever,  Muscle pain in right leg/inability to stand or walk/Inability to maintain balance, Difficulty voiding, Dizziness/Confusion/Disorientation, Rashes,
Patient has been diagnosed with polymyalgia rheumatica; Patient has been diagnosed with shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a patient (pt) of unknown age and gender. The pt's pertinent medical history, concurrent conditions or concomitant medications were not reported. On or about 06-MAY-2010, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage and route of administration were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered sudden onset of neck, shoulder, knee and hip pain. The pt was diagnosed with shingles and polymyalgia rheumatica. It was also specified that the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The events were considered to be related to zoster vaccine live (ZOSTAVAX) vaccination.  Upon internal review, polymyalgia rheumatica was considered medically significant. Additionally, the events were considered to be disabling due to serious, permanent and incurable injuries.
Flu shot was given on 11/09/2001. Thirty-six hours later I had a temperature and the chills and shakes so bad that I had to hold my jaw shut to keep my teeth from breaking. Entire body was shaking violently for 2 hrs. Same thing happened 60 hrs later after shot given.
Patient complained of very sore, painful arm -> swollen and red lower in arm - hurts to touch.
Fever, Severe pain starting in upper right arm (vaccine site) with extreme swelling at injection site (extreme swelling lasted 7 days, injection site still sore after 14 days), pain coninuing up into right shoulder then to neck, down left arm, back, hips, upper legs, knees, calves, and into feet. Muscles and joints throughout body inflamed and very painful. Patient in extreme pain and had difficulty with even minor movements. Muscles around lungs painful especially on inhalation.   Eyelid and eye muscle spasms (eye spasms continuing as of report submission date). A lyme disease test was run to rule this out.  Lyme test negative.  Diagnosis of problems - severe adverse reaction to Td vaccine. Fever lasted 2 -3 days. All over severe muscle and joint pain lasted 7 days. Patient still having difficulty with eyes, muscles and joints at time of form submission which is reason for the "NO" answer in question #9. Patient was seen by Optomolgist for eye problems - diagnosis: part of reaction to Td vaccine - patient to be rechecked 4 months from initial visit.  Patient seen by Rheumatologist for muscle/joint complaints and is receiving physical therapy to address issues.
Rash and or hives formed on chest and neck approximately 1 week after the first COVID vaccine injection. Self treated for three week with Benadryl tables and ointment. Was not getting any better so went to health care provider and received a prescription for Prednisone. Just started the prescription so too early to see if it is effective.
With my first dose I experienced intense neurological symptoms which I still have today. I also experienced extreme burning pain all over my body, my body felt like it was on fire. I thought it was an allergic reaction. I have food allergies and I took cimetidine 400mg which did not help and I continued to have symptoms.  On 03-06-2021 I went to Hotel for senior citizens, at hospital and I felt more comfortable having an RN give me a shot.  When I went to get second dose at the Medical Center, they informed me I would die if I got the second dose.   When I went to get my second dose, I waited 30 minutes, the RN then came back and said , ?I can not give you the vaccine you, would get a stroke and die?. The Rn nurse then called the infectious disease specialist and he said the same thing to me. The Moderna vaccine causes gastrointestinal and neurological problems, and the infectious disease specialist said you have severe neurological problems, I ca not administer you the second dose.
no adverse event; total of 47 patients that received the vaccines after the use-by date.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (total of 47 patients that received the vaccines after the use-by date.) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7642B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 27-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (total of 47 patients that received the vaccines after the use-by date.). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (total of 47 patients that received the vaccines after the use-by date.) and NO ADVERSE EVENT (no adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (total of 47 patients that received the vaccines after the use-by date.).    Patient was over 18 years of age.  No relevant concomitant medications were reported. Staff gave patients vaccines past the use date of 18 Jun 2023. On 27 Jun 2023, 2 doses were administered at administration site 1.  No treatment medication reported.   This case was for the 3rd patient out of 47 reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-732752 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Follow up received, updated vaccination date and I narrative.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732752:Master case (Patient 01)
patient called and reported new itchy, rash at injection site one week after immunization delivery. per patient, she did not experience any injection site reaction immediately following immunization. Patient was advised to follow up with MD/PCP.
Patient received DTaP (right arm) and influenza IM/MENACTRA (left arm) on 1/25/12. Overnight developed pain at both sites. Fever 101 -> spiked to 102. Lethargy, nausea & near-syncopal event w/ fever/nausea. Seen in office - afebrile at that time - after MOTRIN - injection sites slightly tender - no significant erythema - supportive therapy ordered w/ TYLENOL/MOTRIN.
Fever that lasted three days, tiredness, severe heart pains (felt like a heart attack), diagnosed with pericarditis, place on a anti -inflammatory medication, pain around heart and chest  muscles, ribs has popped out, has went to a chiropractor for treatment
vomiting; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 76 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 76 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VOMITING (non-serious), outcome "unknown", described as "vomiting".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
SWEATY (HOT DURING THE NIGHT); TIRED; POOR SLEEP; BAD HEADACHE; SHOULDER PAIN (LEFT ARM); LITTLE SORENESS AT SITE OF VACCINATION; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included depression, and anxiety, and other pre-existing medical conditions included the patient had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on left arm on 12-MAR-2021 17:15 for prophylactic vaccination. Concomitant medications included sertraline hydrochloride for anxiety, and depression, and zolpidem tartrate for insomnia. On MAR-2021, the subject experienced shoulder pain (left arm). On MAR-2021, the subject experienced little soreness at site of vaccination. On 12-MAR-2021, the subject experienced poor sleep. On 12-MAR-2021, the subject experienced bad headache. On 13-MAR-2021, the subject experienced sweaty (hot during the night). On 13-MAR-2021, the subject experienced tired. Laboratory data included: Body temperature (NR: not provided) 98.1 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweaty (hot during the night) on 13-MAR-2021, was recovering from bad headache, had not recovered from tired, and the outcome of poor sleep, shoulder pain (left arm) and little soreness at site of vaccination was not reported. This report was non-serious.
Tested positive for Covid after 1st dose of vaccine; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient receive first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318) via an unspecified route of administration on 01Feb2021 02:21 PM in left arm at single dose for COVID-19 immunisation. The patient medical history included her mom was positive for Covid and concomitant medications were not reported. No vaccines were administered on same date with the Pfizer vaccine considered as suspect. Mom had diabetes. The patient previously took Tylenol and experienced allergy, got a rash and difficulty breathing when she was younger. The patient got her first dose of the vaccine on Monday 01Feb2021. Later that week, either Thursday or Friday, her mom was positive for Covid, so she went and got tested on Friday 05Feb2021. She just got the test results back on Sunday and it was positive also. So she was asking whether she has to start the whole process again, or could she just get the second dose on 22Feb2021 as scheduled. No require a visit to emergency or physician office. She did not know if this would relevant, but she thought she was still allergic to Tylenol. She thought that maybe since she was older that she would have grown out of it, so she took it again on 09Feb2021 while she was sick and it caused difficulty breathing. She was breathing fine until she took the Tylenol, then after taking it she was having a little difficulty breathing, so she thought she was still allergic to Tylenol. The outcome of event was unknown.
This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (lot number, dose and route were unknown). No adverse effects were reported. Additional information has been requested.
Fluzone High-Dose administered that had undergone delayed shipping transit/No AE; Initial information received on 01-Nov-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to cases 2019SA307301, 2019SA307319, 2019SA307321 and 2019SA307322 (same reporter).  This case involves an 85 years old female patient who received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] that had undergone delayed transit during shipping.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 31-Oct-2019, the patient received a 0.5 mL dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ290AB, expiry date- 09-JUN-2020 via intramuscular route in the left deltoid.  It was a case of actual medication error due to incorrect product storage.  At the time of report no adverse event was 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.
feels tired; crummy with body aches; crummy with body aches; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 40 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "feels tired"; MOOD ALTERED (non-serious), PAIN (non-serious), outcome "unknown" and all described as "crummy with body aches".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.