chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm pain began 3:30pm Chills began ~8:00pm Awoke 12:30am with chills, body aches, tingling in R hand and lips. Temp 101.3, went back to sleep in new position to try to be more comfortable. Awoke 3:30am, stood up to use toilet.  Lost bladder control, stumbled to bathroom (approx ten steps).  Sat to use toilet, removed pajama bottoms.  Began to feel dizzy and braced elbows on knees.  Came back to consciousness leaning back over tank of toilet.  Felt extremely sweaty, had to remove shirt, checked temp - 99.3.  Layed on floor, vomited in garbage can.  Texted family and colleagues for help in hopes someone was awake, but got no response.  Decided not to call 911 because I was alone in the house with my 9yo daughter.  Went back to bed and waited for sun to come up, then called my adult daughter.  Took one dose Tylenol.  Remained in bed until following day. Fever spiked again that night to 102.9.
Left arm felt tingly almost immediately. Then tongue felt enlarged and numb. Then left side of face, mouth and nose were numb for 4 hours. Subsided about 90% and around 7:30pm the face and mouth numbness came back. Went to sleep and woke up at 7:30am and numbness had subsided 50%.
an anaphylactic reaction to Fluzone HD; extremely severe reaction of shortness of breath; very hot; palpitations; nausea; room was spinning; dizzy and holding on to the wall; Initial information received on 06-Aug-2020 regarding an unsolicited valid serious case from consumer/non-healthcare professional (patient).  This case involves a 75 years old female patient who had an anaphylactic reaction with the symptoms of an extremely severe reaction of shortness of breath (dyspnoea), very hot (feeling hot), palpitations, nausea, room was spinning (vertigo) and dizzy and holding on to the wall (dizziness), after she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient had ongoing history of minor allergy to penicillin and Crestor drug. The patient's past medical treatment(s), vaccination(s), concomitant therapy and family history were not reported.   On an unknown date in 2016, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (Injection, batch number and expiration date not reported) via intramuscular route in unknown administration site as prophylactic vaccination.  On an unknown date in 2016, the patient developed a serious an  anaphylactic reaction with the symptoms of an extremely severe reaction of shortness of breath (dyspnoea), very hot (feeling hot), palpitations, nausea, room was spinning (vertigo) and dizzy and holding on to the wall (dizziness) , within 12 hours later following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. These events were assessed as medically significant.  No laboratory data reported.  Final diagnosis was anaphylactic reaction.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of events were unknown.  Information on the batch number was requested.; Sender's Comments: This 75 years old female patient developed anaphylactic reaction, 12 hours (as reported) after vaccination with INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE]. Although the time to onset is compatible, there is no information regarding patient's medical condition at the time of vaccination, concomitant therapies, past vaccination and its tolerance and relevant lab tests. Thus, a causal role of the vaccine could not be assessed.
About an hour after I got vaccinated, I started to go into anaphylactic shock. My throat started to close and I was having adrenaline rushes, heart rate instability, and dizziness. I felt very shaky and weak. I was able to reverse it with Benadryl and other antihistamines. I did not need my Epipen. My symptoms subsided after about 4-5 hours. I did not eat anything after getting the shot, and I was not exposed to any other allergen that could have caused an anaphylactic reaction. I have not started any new medications that could have caused this either. I believe my reaction was related to the vaccine.
After she had both flu and Covid booster shots on the same day she had to rest for 2 days. After then her memory started to deteriorate. I took her to the ER on November27 where they did a battery of test and could find nothing wrong. Her condition continued to deteriorate over the next 3 weeks so I had her admitted to the Sarasota Memorial Hospital on Dec 17 . Again they could find nothing wrong and she was deteriorating rapidly She was moved to hospice on 27 Dec where she is now basically unconscious with very slow breathing.
got shingles from the vaccine (shingrex)/suspected vaccination failure; got shingles from the vaccine (shingrex); This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   The reporter considered the vaccination failure and shingles to be related to Shingrix.     Additional Information: GSK receipt date: 5-June-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient actually got shingles from the vaccine (shingrex). It was very rare. The patient stated that if you get symptoms after don't ignore them. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles was not provided.
Patient on warfarin. Had large red-blue bruised area with golf-ball sized welt at injection site.
Pt became very fatigued, soreness all over, nausea and vomiting. Pt was re-evaluated after 24 hours. This was shot #5 on series.
The pt. developed a splotchy rash on calf and arm. The pt. applied benadryl cream to affected areas and redness decreased.  She also was going to take benadryl capsule orally, apply an ice pack, and take famotidine tablets as well.
swelling, redness, warm to touch, rash, bruising, was eval'd 06/06/2019 in ER
Had a 102 fever for more than 48 hours. Extreme muscle pain for 48 hours. Extreme fatigue for 72 hours. Ran a fever of 99-100 for several hours a day for the next 10 days
Im also having ear pains,; Have a 101.5 fever; A headache; Muscle aches; Weakness everywhere; Tiredness; chills; This is a spontaneous report from a contactable consumer, the patient. A 19-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0187), via an unspecified route of administration in the right arm on 25May2021 at 17:30 (at the age of 19 years-old) as single dose for COVID-19 immunisation. The patient had history of known allergies to baby oil (mineral oil). The patient did not receive any concomitant medications. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26May2021 at 00:00, the patient experienced 101.5 fever, a headache, muscle aches, weakness everywhere, tiredness, chills and also having ear pains that felt like an ear infection. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of 101.5 fever, a headache, muscle aches, weakness everywhere, tiredness, chills and also having ear pains were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Employee called the nurse line reported adverse reaction to second covid vaccine. Caller received vaccine at 1330 and started to have vision changes bilaterally of halos around vision lasting for 10 minutes at a time and a slight headache
This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. Nurse had previously called on 21-JUN-2013 to discuss vaccine temperature stability data at that time reported no patients had received improperly stored vaccine. On 27-JUN-2013, nurse reported that she discovered 3 patients received improperly stored vaccine. On 20-JUN-2013, one of the patient received an improperly stored dose of GARDASIL (lot#, expiry not reported). No symptoms reported. This is 1 of 3 reports received from the same reporter. Additional information is not expected.
Hoarseness, loss of voice, and phlegm starting the day following the second vaccine.  Difficult to clear throat, phlegm has persisted for the past week, now leading to a persistent fits of coughing starting today.
Swelling, extreme redness from above elbow to shoulder. This was 4 days after injection.
had long term super hypersensitive skin; flea bites right after the vaccine, had a horrible time with them, & it took months for them to heal; Her psoriasis had bigger breakouts than ever before; had poison ivy that was worse than ever; got shingles diagnosed on 27Aug2021/had shingles symptoms for a week before being diagnosed; 1st dose 9Mar2021; 2nd dose 21Apr2021; This spontaneous case was reported by a consumer and describes the occurrence of SENSITIVE SKIN (had long term super hypersensitive skin), ARTHROPOD BITE (flea bites right after the vaccine, had a horrible time with them, & it took months for them to heal), PSORIASIS (Her psoriasis had bigger breakouts than ever before), DERMATITIS CONTACT (had poison ivy that was worse than ever) and HERPES ZOSTER (got shingles diagnosed on 27Aug2021/had shingles symptoms for a week before being diagnosed) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 9Mar2021; 2nd dose 21Apr2021). On 27-Aug-2021, the patient experienced HERPES ZOSTER (got shingles diagnosed on 27Aug2021/had shingles symptoms for a week before being diagnosed). On an unknown date, the patient experienced SENSITIVE SKIN (had long term super hypersensitive skin), ARTHROPOD BITE (flea bites right after the vaccine, had a horrible time with them, & it took months for them to heal), PSORIASIS (Her psoriasis had bigger breakouts than ever before) and DERMATITIS CONTACT (had poison ivy that was worse than ever). On 21-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 9Mar2021; 2nd dose 21Apr2021) had resolved. At the time of the report, SENSITIVE SKIN (had long term super hypersensitive skin), ARTHROPOD BITE (flea bites right after the vaccine, had a horrible time with them, & it took months for them to heal), PSORIASIS (Her psoriasis had bigger breakouts than ever before), DERMATITIS CONTACT (had poison ivy that was worse than ever) and HERPES ZOSTER (got shingles diagnosed on 27Aug2021/had shingles symptoms for a week before being diagnosed) outcome was unknown.            No Concomitant medication was reported.  No treatment medication was reported.
Child developed "hives" on his head and neck.  Was taken to family physician who described hives as "atypical".  Given steroids.  One day later after seeing MD (02/09/2012) hives had spread to waist and trunk of body.
received Havrix that had been exposed to a freezing excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received HAV (Havrix) (batch number 5575N, expiry date 19th June 2020) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. A medical assistant reported that the patient received Havrix that had been exposed to a freezing excursion, which led to Incorrect storage of drug The reporter consented to follow up. This is 1 of 11 cases reported by same reporter.
Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Seizure-Severe
This spontaneous report as received from a currently 68 year old female patient, regarding herself. The patient had no pertinent medical history and drug reactions/allergies. The patient's concomitant medication included unspecified blood pressure medications. On an unknown date (reported as: years back), the patient was vaccinated with first dose of PNEUMOVAX 23 (dose, frequency, lot #, expiry date and route were not reported) for prophylaxis. On 17-SEP-2018, the patient was vaccinated with second dose of PNEUMOVAX 23 injection (0.5 ml) (lot # and expiry date were not reported) for prevention of pneumococcal disease. About an hour later, the patient experienced pain, warmth, and swelling at the injection site and redness on her arm below the injection site. The patient also stated that she experienced chills and fever after receiving the vaccine. The patient experienced pain at the injection site extended to the back of shoulder. On 18-SEP-2018 (reported as: as of yesterday) the patient was unable to lift the arm, but today she can lift it a little higher. The patient received unspecified treatment for the events. Lab diagnostics/studies was not performed. The patient sought medical attention for the event (called doctor's office). No product quality complaint was involved. The outcome of events was reported as recovering/resolving. The relationship between the events and PNEUMOVAX 23 was not provided.
Flu shot administered at PCP office in (R) upper arm. Started developing redness/pain the next day. Continued to worsen until pain became significant. Did not check temp but had chills. She came to the ED & noted leukocytosis & sig. swelling of arm. Admitted for abx as she is immunocompromised.
This case was reported by a healthcare professional and described the occurrence of fever in a 4-month-old male subject who was vaccinated with Pediarix for prophylaxis. Concurrent vaccinations given the same day included Haemophilus influenzae type B vaccine; pneumococcal vaccine and rotavirus vaccine. On 14 June 2007 at 17:30 the subject received 2nd dose of Pediarix (unknown). On 14 June 2007, within 24 hours after vaccination with Pediarix, the subject experienced fever of 102 degrees Fahrenheit. The fever increased to 103.6 degrees Fahrenheit. The subject was hospitalized overnight. At the time of reporting the outcome of the event was unspecified.
03/08/2023- I had mild cold symptoms; coughing and a low grade fever. I contacted Urgent Care and was prescribed a course of Paxlovid. I still have a lingering cough.
Felt tiredness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Felt tiredness) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced FATIGUE (Felt tiredness). At the time of the report, FATIGUE (Felt tiredness) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were provided.  The patient does not does not have lot numbers for any of his Covid-19 vaccinations and does not remember dates of vaccination. The patient reported no other Adverse Events.  No treatment medications were provided.   This case was linked to MOD-2022-554825, MOD-2022-554828 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2022: Follow-up document contains no new information.
At around 9:25 am on Thursday, June 17th, 2021, seventeen-year-old patient walked into the vaccination site. She was accompanied by two guardians, along with 14 other minors. The minors came in for their 2nd shot of Pfizer Covid-19 vaccines.  Patient signed all necessary consent forms and pre-vaccination checklist requirements with guardian and entered the vaccination section at around 9:35 am. The Pfizer vaccine was administered at 9:39 am.  Observation nurse reported that around 10:06 am the patient complained about having a severe headache, ?seeing stars?, feeling very dizzy, and not feeling well. Nurse assisted patient to lay down on the mat in case the patient may faint. Charge nurse obtained a pulse oximetry reading of 95% and a pulse of 96.   Charge nurse checked if the patient experienced any symptoms of hives/redness, shortness of breath, or any difficulty breathing or swallowing. The patient complained to observation nurse that she was having a hard time breathing, severe headache, and chest pain.   Observation nurse instructed patient to be calm and to relax. Charge nurse instructed the patient to take deep slow breaths to help increase O2 levels but the patient complained to the observation nurse that she cannot breathe through her nose.   At 10:15 am charge nurse continuously monitored the patient?s B/P, pulse, and O2 level readings. The BP reading was 117/64 with a pulse of 78 and an O2 level of 100%. At approximately 10:16 am, patient started showing signs of change in LOC and lost consciousness for a few seconds. First responder paramedics from the first minor incident were still at the scene waiting for the 2nd ambulance to arrive. The first responder paramedic did a sternum rub using his knuckles with a closed fist to the center of the patient?s chest and immediately after the patient gasped for air and regained consciousness. The patient remained in a sitting position on the floor to be able to breathe easier. At approximately, 10:18 am charge nurse took another BP reading of 121/76, a pulse of 96, and O2 level of 99%.   At approximately 10:20 am, patient started exhibiting a change in LOC and was very disoriented again. Observation nurse kept calling the patient?s name but did not get a response. This lasted for around 30 seconds while the patient gasped for air before becoming responsive again. At this time observation nurse observed that patient could not recall her name and did not know how she got there.   At approximately 10:22 am, charge nurse took another BP reading of 165/133, a pulse of  122, and an O2 level of 96%.   At around 10:24 am, the charge nurse took another BP reading of 112/78 and pulse of 112 with an O2 level of 96%. The second ambulance arrived at approximately 10:26 am and took over.   The second ambulance?s first responder paramedics left with patient at approx. 10:29 am and took her to hospital for further observation.
Patient received second Moderna vaccine at vaccine event.  He had reported some post vaccine tingling with first vaccine, so he was triaged after second vaccine to the 30 minute observation  area.  He again complained of left sided tingling and also subjective numbness of face and tongue.  His exam was normal.  Normal cranial nerve function.  Normal speech. Normal VS.  No meds administered.  Given some snacks.  Symptoms resolved over course of another 30 minutes.  Discharged to home without incident
Admission Date: 8/22/2021   Date of Death: 8/31/2021 actual Time of Death: 9:35 am   Autopsy Scheduled/Performed: No   Manner of Death: Natural   Cause of Death:   COVID-19 pneumonia 9 days   - interval between onset and death Acute hypoxic respiratory failure Obstructive sleep apnea on respiratory support patient has not been compliant with weight prior to this hospital stay Chronic osteomyelitis Quadriplegia   Hospital Course:  Patient presented with increased weakness hypoxia and hypotension.  Patient has history of chronic osteomyelitis and also he has quadriplegia.  Patient was admitted started on broad spectrum antibiotics and shortly after admission he required pressors so he was transferred to the intensivist service.  Patient also required significant amount of oxygen and that was providing using BiPAP.  Once the patient was off of pressors he was transitioned to hospitalist service.  Patient developed A. fib with rapid ventricular response cardiology service was consulted and also he was treated with amiodarone.  Patient developed worsening infiltrates with increased opacification of the left lung.  Initial testing in the emergency room turned back positive for coronavirus.  Patient did have the 2 doses of vaccine given approximately 6 months ago.  Pulmonology service was consulted due to opacification of the left lung but patient refused bronchoscopy.  To note even prior to this hospital stay patient has been declining regarding ability to function.  Minimal activity was causing significant shortness of breath.  Patient continued to deteriorate and he became hypoxic despite using BiPAP on a maximum settings with FiO2 of 100%.  In view of her rapid deterioration patient was intubated but after discussing with family it became clear that patient does not want to be on prolonged mechanical ventilation and that would have been the best outcome in view of his previous deterioration in pulmonary function on top of his pneumonia and COVID-19 disease.  Patient was extubated the same day and he died shortly after being extubated.  Discharge Diagnoses:  Acute hypoxic respiratory failure secondary to COVID-19 pneumonia and bacterial pneumonia worsened by patient quadriplegia and decreased cough reflex   Septic shock likely source multilobar pneumonia other possibilities UTI with chronic enduring catheter and chronic osteomyelitis   COVID-19/SARS-CoV-2 viral infection patient treated with remdesivir and dexamethasone   Partial quadriplegia from an old accident with neurogenic bladder and also with colostomy   Anemia acute on chronic acute component likely related to present illness   ICU delirium
Soreness at injection site (left deltoid), redness around injection site. Weakness, short of breath, malaise.
Patient came into to the pharmacy on 7/4/21 with a red elevated rash on the left deltoid approximately 3 in. by 3 in. The rash started on 6/26 (the day after receiving the vaccine) and has only gotten worse since then.  The patient stated that the pharmacist did not wear gloves while giving the vaccine and was concerned that could have aided in causing the rash.  She stated that it didn't itch, but she had achy pain throughout the entire upper arm and the rash was hot to the touch.  She denied any burning or stinging pain, and had not tried any medications to help treat the rash.  I advised her to take benadryl and aleve/ibuprofen to help with the rash and swelling.  Since it was Sunday when the patient came to the pharmacy, I advised her to see a doctor by Wednesday if the rash hadn't improved while taking those medications or if it got any worse.