chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer and described the occurrence of fever in a 54-year-old male subject who was vaccinated with combined DTP (A or W not known) vaccine. This case also described the occurrence of episode of atrial fibrillation after the subject received ADVAIR 100/50 mcg multi-dose powder inhaler over a period of two days for asthma and cough. A physician or other health care professional has not verified this report. The subject's medical history included atrial fibrillation and hyperthyroidism. Concurrent medical conditions included asthma and cough. There were no concurrent medications. On 22 February 2010 the patient started Fluticasone propionate+salmeterol xinafoate (inhaled) at 2 puff(s) twice per day. Approximately 1 day after starting Fluticasone propionate+salmeterol xinafoate, after his third or fourth dose of ADVAIR, on 23 February 2010, the patient experienced episode of atrial fibrillation. The episode of atrial fibrillation lasted from approximately 1:30 p.m. on 23 February 2010 until 10:00 a.m. on 24 February 2010. On 24 February 2010 the subject received a booster dose of DTP vaccine, unspecified (unknown). On 24 February 2010, the same day that he received DTP vaccine, unspecified and two days after starting Fluticasone propionate-salmeterol xinate, he developed a fever of 101 degrees Fahrenheit. The fever resolved on 25 February 2010. Fluticasone propionate+salmeterol xinafoate was discontinued. This case was assessed as medically serious by GSK. The patient reported an adverse reaction (fever 101 degrees Fahrenheit) to DTP vaccine. He needed a tetanus update and was administered the unknown brand vaccine during a doctor visit. His physician believed that the vaccine was not necessarily the cause of his reported fever. The patient also reported an extended episode of atrial fibrillation after his third or fourth dose of ADVAIR Diskus 100/50 mcg. He was taking ADVAIR for a cough, which immediately resolved following one dose of ADVAIR Diskus. Patient has history of hyperthyroidism, but was not on any medication for this condition at the time of the event. The patient was 19 yrs old at the time of his hyperthyroidism diagnosis. Patient also had a history of atrial fibrillation and had been on blood thinner and beta blocker medications in the past. Patient was not on any medication at the time of the event save for ADAIR 100/50. Patient reported he was under exceptional stress at work and had had a birthday that week. In addition, the patient reported that he has not attended to his nutritional needs of late. These he believed were contributory to the episode of atrial fibrillation as well as the ADVAIR. The extended episode started at 1:30pm and continued until 10:00 am the next day. Patient indicated that his atrial fibrillation episodes usually occur in the middle of the night. Patient stopped using his ADVAIR medication with the onset of the episode, despite his physician's belief that the medication was not the cause of his unusual atrial fibrillation episode.
Initial information received from a health care professional on 15 October 2010. A 75-year-old male patient with a history of severe cardiopulmonary issues (unspecified), cataracts, and who was "crippled", received a dose of FLUZONE HIGH-DOSE No Preservative 2010-2011, lot number U3635AA, on 13 October 2010 at 10:00 a.m. The route and site of vaccination were not reported. Following vaccination, the patient experienced no adverse events or reactions and was reported to be "fine" at 8:30p.m. that evening. The following day, on 14 October 2010 at 11:00 a.m., he was found dead by his sister. Autopsy status is unknown and no cause of death was reported. Per the reporter, the patient had been very ill prior to vaccination and his quality of life was poor. Follow-up information received on 18 October 2010 from a health care professional. The reporter stated that it is unknown if an autopsy was planned for the patient, but that if the patient had been seen by one of their physicians during the month prior to the event it is unlikely an autopsy would be performed. In addition, the reporter stated that the patient's past medical history of cardiopulmonary issues (unspecified) were "more cardiac rather than pulmonary", but no specifics were provided. List of documents held by sender: none
Pt recv vax on 10/21/98; 1 hr post vax pt exp painful arm w/ redness, swelling, fever; dx=blood poison, tx=Dexamethasone, Ciphril
Swelling under the left armpit and pain in the right elbow that has not yet gone away.; Swelling under the left armpit and pain in the right elbow that has not yet gone away.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Feb2021 11:00 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Depresión" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 (Anatomical location: Arm Left, Dose Number:01), administration date: 10Feb2020, when the patient was 40 years old. The following information was reported: PERIPHERAL SWELLING (non-serious), ARTHRALGIA (non-serious) all with onset 11Feb2021, outcome "not recovered" and all described as "Swelling under the left armpit and pain in the right elbow that has not yet gone away.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information- The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no list of any other medications the patient received within 2 weeks of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient tested for COVID-19. The patient did not have allergies to medications, food, or other products.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Symptoms: shortness of breath, coughing, extreme fatigue, racing heart, high blood pressure began right after 2nd dose. It continued to get worse and in June it was treated as asthma not controlled.  In September I went to the ER due to not being able to breath. The heart failure was discovered after being admitted. I was treated with multiple medications and had multiple tests while in the hospital.
Patient called stating his arm is red, swollen & very painful. He took some rx pain reliever with no relief. Told patient to go to clinic for evaluation; where he was refused treatment. Patient drove back home w/a 103 degree fever. His doctor stated there is nothing they can do for him & not to worry.
An 80 year old male patient, diagnosed with bladder cancer in situ, received an initial Tice BCG instillation on 12/30/2002.  On 12/31/2002 the patient developed a high fever (102 degrees F), muscle soreness and significant fatigue.  He had also been experiencing urinary urgency and frequency.  He reported his symptoms to his treating urologist on 01/02/2003.  Following corrective treatment he was afebrile and his muscle soreness had resolved by 01/04/2003.  The fatigue and urinary urgency/ frequency have persisted, but have lessened.  It is unknown if further Tice BCG therapy will be received.  01/02/2003- Levaquin 500mg/day for 8 days (for presumed urinary tract infection), Rifampin 600mg QD and Isoniaside 300mg QD
receiving doses from vials affected by a temperature excursion; received doses from vials affected by a temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (received doses from vials affected by a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (receiving doses from vials affected by a temperature excursion) in a 58-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 049l21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-May-2022 at 10:46 AM, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 26-May-2022 at 10:46 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (received doses from vials affected by a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (receiving doses from vials affected by a temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (received doses from vials affected by a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (receiving doses from vials affected by a temperature excursion) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  Patient had received full dose. Patient received dose from first vial. It was reported that 20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range. It was reported that no adverse event occurred at time of administration or were reported thereafter.  Treatment medication was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2022: Follow-up received contains patient details added, product start date, new event added, event onset date added and narrative updated.
Given JNJ Covid vaccine on 6/15/2021 in left arm, IM, lot number 205A21A and given JNJ Covid vaccine on 7/21/2021 in left arm, IM, Lot number 204A21A. Person did answer the question Have you received a dose of Covid-19 vaccine as no both times. Both doses were given by this reporter.
Began to have mild headache, mild tiredness, and mild chills on 12/28. Followed up with PCP who advised that the symptoms should resolve in a few days.
mom states daughter had Hep B in Left arm on 7/23/03.  She developed redness in 1-2 days after vaccination which developed inot a sore.  She reported the incident 8/22/03.
Patient received Moderna COVID19 vaccine on 8/31/22 that was expired on 8/27/22.
THE JANSSEN COVID 19 VACCINE WAS REFROZEN; ADMINISTERED REFROZEN VACCINE; This spontaneous report received from a health care professional concerned a 47 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine ad26. cov2. S (unspecified manufacturer) (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1821286, expiry: 20-MAR-2022) dose was not reported, 01 total, administered on 09-SEP-2021 for prophylactic vaccination. It was unknown whether patient had any adverse reactions following vaccination with covid-19 vaccine ad26.cov2.s. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 212A21A, expiry: 20-MAY-2022) dose was not reported, 01 total administered on 09-FEB-2022 for prophylactic vaccination in left arm. Age at time of vaccination 47 years old. No concomitant medications were reported. On 09-FEB-2022, the patient had been administered refrozen vaccine (Dose number in series 2). On an unspecified date, the janssen covid 19 vaccine was refrozen (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the the janssen covid 19 vaccine was refrozen and administered refrozen vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20220538428, 20220538297, 20220538573, 20220538480, 20220538149, 20220538379, 20220538437, 20220537688, 20220537507, 20220538627, 20220537683, 20220537341, 20220537444, 20220538292, 20220537548, 20220538411, 20220537356, 20220539045, 20220538425, 20220538316, 20220538210, 20220538238, 20220538758 and 20220540524.
pt recv vax 8JUL97 & 9JUL97 pt exp soreness, redness, swelling & warmth @ the inj site;
I got Bell's Palsy.  Over 5 weeks later and still no improvements.  Also have severe  vertigo from the Bell's Palsy and cannot work.
0835 the patient was given the vaccine in the right deltoid IM, at approximately 0838 the patient started feeling tingling and tightness in her upper chest and neck. She stated her throat was feeling funny and the back of her tongue felt like it was getting bigger and swelling. The patient did not have any difficulty breathing. At 0845 Benedryl 25mg IM was administered. Patient vital signs BP 156/88, HR 86, R 22, O2 Sat 98%. Respirations were even and unlabored. Patient was observed and within a few minutes stated that she felt better and was no longer feeling the tingling, tightness or tongue swelling. We continued to observe the patient for 45 minutes after her initial reaction. 0855 Dr. assessed the patient and determined her to be stable. 0945 At time of dismissal, VS BP 125/82, 74, 18, 99%. Patient had no complaints other than drowsiness and respirations were even and unlabored. Patient left by ambulation in stable condition.
crying x 30hr; adm to ER for observation;disch from hosp 10/22/99 AM;
Information has been received from a female consumer concerning her 5 year old son with amoxicillin allergy and seasonal allergy who on 22-MAY-2006 was vaccinated with a dose of PROQUAD (Merck). After vaccination her son presented with a fever of 104 degrees, severe diarrhea, a mild rash on his body, lethargy and an ear infection. Patient also had behavior changes and was diagnosed with autism. The patient sought unspecified medical attention. At the time of report the patient's status was not recovered. Upon internal review, autism was considered to be an other important medical event. This is one of several reports from the same source. It was also reported that the patient was vaccinated with a dose of MMR II and experienced an adverse event (WAES 1008USA03776). Additional information has been requested.
headache; increased temperature; This is a spontaneous report from a program. A contactable consumer (patient's husband) reported that a female patient of an unspecified age (Age: 65, unit: unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number, and expiration date not reported), via an unspecified route of administration on 10Mar2021, as first dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced headache and increased temperature (reported as for a few minutes) on an unspecified date. Reporter inquired if patient can take paracetamol (TYLENOL). The patient underwent lab tests and procedures which included body temperature: increased on an unspecified date. The outcome of all events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Flushing of face, tingling from head to knees, throat felt tightened but not closed completely, no difficulty breathing
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 61 year old female, race and unknown ethnicity. The patient's weight was 130 pounds, and height was 60 inches. The patient's concurrent conditions included: thyroid problem, seasonal allergies, penicillin allergy, non alcoholic, and smoker (Half a packet per day). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: Unknown) dose was not reported, administered on 18-MAR-2021 to left arm for prophylactic vaccination. Concomitant medications included cetirizine hydrochloride for thyroid problem.  On 28-AUG-2021, the patient performed antibody test in order to check presence of antibody after vaccination and  the result was negative. Laboratory data included: Antibody test (NR: not provided) Negative (finger prick test with results within 15minutes). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210858647-COVID-19 VACCINE AD26.COV2.S-Confirmed immunological vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
After receiving the third dose tinnitus started in both ears sometime in December. I will be seeing an ENT later in May 2022.
Tested positive for covid; Tested positive for covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old male patient received BNT162b2 (BNT162B2), on 26Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 16Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 27Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 29 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovering" and all described as "Tested positive for covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (29May2022) Negative, notes: Tested positive for covid again with Symptoms of fever/chills/muscle aches 4 days after completing the full course of paxlovid. I had previously tested Negative on the 3rd day following Completion of treatment; (31May2022) Positive, notes: Tested positive for covid again with Symptoms of fever/chills/muscle aches 4 days after completing the full course of paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
severe generalized pruritis and erythema. diphenhydramine 50mg PO. Epinephrine autoinjector 0.3mg IM.
This is her second moderna vaccine.  She felt numbness and tingling in her upper and lower extremeties.
This spontaneous report as received from a physician's assistant refers to a patient of unknown age and gender. On 24-SEP-2015 the patient was vaccinated with an improperly stored dose of MMRII (lot # L003855 exp date 05-FEB-2017) (dose and route not reported). The temperature excursion was 53.8 F for 10.75 hours from 17-AUG-2015 to 06-NOV-2015. No adverse event was reported. This is one of several reports from the same source. Additional information is not expected as all follow up information to complete the case was received.
vaccine administered on monday may 13, patient called 5-20-19, stating that she began experiencing a burny throat, tingling lips and joint pain on wednesday may 15 and beginning friday may 17 and into saturday may 18 she had dull headache, flu like symptoms and very tired and on monday May 20 when she called the pharmacy she stated that she still was experiencing pain in her left arm from the injection
Spleen enlarged up to six times normal size, itchy from head to toe, fever of 99.4 (treated with tylenol), aches, joint pain, arms red, swollen and sore from shoulder to elbow.
Headache, Myalgia, Fever & NauseaVomiting  Narrative: chills, fever, muscle ache/extreme fatigue, headache and nausea for 48 hours (1/21 and 1/22)
Pt received vaccines on 3/17/00, Mom called on 3/20/00 stating he had been screaming since 3/17/00 with fever of 101. She was advised to take the child to an urgent care facility since it was after office hours.
STORAGE REFRIGERATOR (2C-8C) UP TO 30 DAYS. (VACCINE USED AFTER 10-16-2021).
8PM PT. STARTED BREAKING OUT WITH HIVES, HAVING SEVERE ITCHING, CALL PLACE TO OFFICE (OFFICE HOURS CLOSED) S/W DR., ADVISED TO MEDICATE WITH BENADRYL. ONLY HAD TO BE MEDICATED ONCE.
Injection site was red, hot; The injection site was red; Injection site was red, hot and swollen; A spontaneous report (United States) was received from a consumer concerning a 80-years-old patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced injection site was red/ vaccination site erythema, hot/ vaccination site warmth and swollen/ vaccination site swelling.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 22 Jan 2021, approximately nine days prior to the onset of the events the patient received their dose of mRNA-1273 (Batch Number: 029L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 30 Jan 2021, the patient experienced arm at the injection site was red, hot and swollen.  Treatment for the events included an ice pack and paracetamol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, injection site was red, hot and swollen was resolving (it is better).; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Swelling on her forehead; Bruising on her forehead; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of SWELLING FACE (Swelling on her forehead) and CONTUSION (Bruising on her forehead) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWELLING FACE (Swelling on her forehead) (seriousness criterion medically significant) and CONTUSION (Bruising on her forehead) (seriousness criterion medically significant). At the time of the report, SWELLING FACE (Swelling on her forehead) and CONTUSION (Bruising on her forehead) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product use was provided. Treatment information was not available.  Very limited information regarding these event/s have been provided at this time.  Further information has been requested.   This case was linked to MOD-2021-066254 (Patient Link).; Sender's Comments: Very limited information regarding these event/s have been provided at this time.  Further information has been requested.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On 16-NOV-2006, the patient received the first dose in the series of three of GARDASIL (dose, route of administration, lot # and expiration date were not provided). On 06-MAR-2007, the patient received the second dose in the series of three of GARDASIL (dose, route of administration, lot # and expiration date were not provided). On 18-MAY-2007, the patient received the third dose in the series of three of GARDASIL (dose, route of administration, lot # and expiration date were not provided). No adverse effects were reported. Additional information has been requested.