chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Drug ineffective; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Lot number: Fk9893) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "allergies" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "depression" (unspecified if ongoing); "known allergies: Peanuts" (unspecified if ongoing), notes: known allergies: Peanuts; "known allergies: cashews" (unspecified if ongoing), notes: known allergies: cashews; "known allergies: soy" (unspecified if ongoing), notes: known allergies: soy. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "not recovered"; COVID-19 (medically significant), outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Treatment of COVID-19; (20Jun2022) Negative, notes: Tested negative 20Jun and then tested positive (21Jun-22Jun); (21Jun2022) Positive, notes: Tested negative 20Jun and then tested positive (21Jun-22Jun); (22Jun2022) Positive, notes: Tested negative 20Jun and then tested positive (21Jun-22Jun). Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are needed. No further information is expected.     .
fainted twice w/in 5 mins; 7AM; 15OCT93; felt dizzy til noon;
The adverse event that occurred was lesions, rashes, and bumps that I began seeking medical attention on April 13, 2021.  This was a gradual process and after multiple visits and biopsies. Finally, I was diagnosed on August 25th Lymphomatoid Papulosis. After months of suffering with what appeared to be my immune system overreacting I finally had a diagnosis.  The Dr. suggested a Methotraxate regiment as a solution to my condition, however I had to gain clearance with some medical test to receive treatment.  On August 27th, I took the test for Hepatitis B, LDH, TB and others including COVID-19.  After COVID Diagnosis, August 29 my issues started to clear up.
Facial paralysis; This is a spontaneous report from a contactable consumer (patient). This 41-year-old non-pregnant female consumer (patient) received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EN6205) in left arm, on 01Apr2021 at 10 AM, for COVID-19 immunisation. No other vaccine was given in 4 weeks. Medical history included asthma and migraines. The patient did not have COVID prior to vaccination. Known allergies: No. Other medications in two weeks: medications for pain in knees were injected. On an unspecified date the patient experienced facial paralysis. The event required treatment (physical therapy) and had not yet resolved at the time of report. COVID was tested post vaccination, on 05Mar2021: nasal swab sample/molecular was negative.
This spontaneous report as received from a pharmacist refers to a patient of unknown demographics. No concurrent conditions or medical history were provided. On 04-AUG-2014, the patient was vaccinated with a dose of improperly stored ZOSTAVAX 0.65 ml, subcutaneously (lot # K000995, expiry date: 16-MAR-2015 (reported as 06-MAR-2015); indication unspecified. No concomitant medications were reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Removing bandaid from upper left arm and noted redness, warmth, itching, and swelling that encompassed back of left upper arm.
Patient was given her first Hepatitis B shot on her right arm. Within 1 or 2 minutes, I administered a seasonal flu shot in her left arm. Immediately after the patient slumped over and started to shake and passed out for 5 seconds. When she came too, the first thing that she asked was how long she was out for. The patient stated that she has episodes of hypoglycemia in the past. I stayed with her, offered her water and gave her 2 glucose tablets to help her feel better. We called 911 and they came and took her to the local ER.
The patient experienced varicella on her face, legs, head and trunk and wheezing. The patient received symptomatic treatment.
Patient came to pick up a sticker and she looked pale, lips were white. She said she was tired and laid down on the floor. I picked up patient and carried her to an exam room and got doctor from a room. Dr. came into the room told me to get oxygen and started to exam patient. Also, said to call her EMS. Oxygen was administered to the patient. Doctor splash water on patient face. We got the Admon bag and doctor used this on patient. Doctor checked patients heart and listened. EMS arrived and doctor informed EMS. patient was alert and stable, oxygen level was between 98 - 100 and heart rate 70 without oxygen. Patient was given orange juice twice while being observed before going home with grandma/guardian. Grandma and doctor discussed no taking patient to the hospital since patient was doing better. Grandma is a RN and said she would keep an eye on her.
Vasovagal reactions; fatigue; dizziness; This is a spontaneous report from a non-contactable consumer, the patient. A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the left arm on an unknown date in 2021 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021 at 11:00 the patient experienced vasovagal reactions, fatigue and dizziness for over a week afterwards. The events did not result in doctor or other healthcare professional office/clinic visit.  No therapeutic measures were taken as the result of adverse events.  The clinical outcome of the events vasovagal reactions and fatigue was not recovered at the time of this report, whereas dizziness was recovered after a week on 13Apr2021.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Her entire left thigh swelled to twice its normal size. It was painful to the touch. The swelling and pain lasted for several days.
Severe swelling, itching and pain in right side of mouth, chin and cheek.  Swelling inside the mouth, itching, slight swollen tip of the tongue on the right side
Approx 12-18 hrs after receiving Rotavirus. PEDIARIX, PREVNAR, flu vaccine patient had jerking movements at home. Taken to ER. Observed overnight. No fever, EEG normal.
Redness and swelling in arm just below injection site.  Approximately 4 inches x 4 inches.  Area remained red, swollen, hot and itchy for 6 days before clearing.
Immediately after 2nd COVID vaccine was taken out of his arm, he felt a  psychedelic high.   Since then, he has been having lapses in memory and what he describes as brain fog or jolts to his body.
Idiopathic urticaria; Got checked for lice. All over body come and go; Hives that were so itchy/ itching is worse at night the histamine reaction; Hives that were so itchy; This spontaneous case was reported by a consumer and describes the occurrence of IDIOPATHIC URTICARIA (Idiopathic urticaria), PRURITUS (Hives that were so itchy/ itching is worse at night the histamine reaction), URTICARIA (Hives that were so itchy) and LICE INFESTATION (Got checked for lice. All over body come and go) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034F21A, 048A21A and 039A21A) for COVID-19 vaccination.     The patient's past medical history included Celiac disease. Concurrent medical conditions included Gluten free diet (The patient is on a strict diet such as no gluten). Concomitant products included VITAMINS NOS (DAILY MULTIVITAMIN) for an unknown indication.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Nov-2021, the patient experienced PRURITUS (Hives that were so itchy/ itching is worse at night the histamine reaction) and URTICARIA (Hives that were so itchy). On an unknown date, the patient experienced IDIOPATHIC URTICARIA (Idiopathic urticaria). an unknown date, the patient experienced LICE INFESTATION (Got checked for lice. All over body come and go). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at a dose of 40 mg 10mg take 4x. At the time of the report, IDIOPATHIC URTICARIA (Idiopathic urticaria) and PRURITUS (Hives that were so itchy/ itching is worse at night the histamine reaction) had not resolved and URTICARIA (Hives that were so itchy) and LICE INFESTATION (Got checked for lice. All over body come and go) outcome was unknown.     The doctor stated that they have seen hives in those with atopic celiac disease after booster patient showing strong immune response such as hives.
She received the vaccine Tuesday morning 6/5. She notes pain in the injection area starting Tuesday evening and a rash and minor swelling around the injection site starting Late Tuesday into Wednesday. I examined the area Thursday (6/7), the injection area is red with some swelling and feels warm to the touch, it appears to me to be an injection site reaction.
This case was reported by a healthcare professional and described the occurrence of musculoskeletal pain in a 70-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline), seasonal influenza vaccine (non-gsk). On 29 October 2012 at 09:00 the subject received booster dose of BOOSTRIX (.5 ml, unknown, right deltoid) and seasonal influenza vaccine (Non-GSK) (unknown). On 1 November 2012, 3 days after vaccination with BOOSTRIX and seasonal influenza vaccine (Non-GSK), the subject experienced musculoskeletal pain. The subject experienced musculoskeletal pain around her rib and pain when turning her neck which radiates to her back and chest. The healthcare professional did not know if the influenza vaccination that the subject received was also a co-suspect vaccine. At the time of reporting the event was unresolved.
Information has been received from a physician concerning a male pt who was vaccinated with 1 dose of pneumococcal vaccine 23 polyvalent and subsequently, the pt was "generally ill." The pt sought unspecified medical attention. Additional information has been requested.
Intermittent itching. Occurs mostly at the spot but sometimes felt on face, neck, and other arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 51-years-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Dec2021 12:30 (Lot number: Unknown) at the age of 51 years as dose1, single for covid-19 immunisation. Relevant medical history included: "HBP" (unspecified if ongoing); "Rheumatoid arthritis" (unspecified if ongoing); "alpha thalassemia" (unspecified if ongoing). Concomitant medication(s) included: PLAQUENIL S; HCTZ. Past drug history included: SULFA for drug hypersensitivity; Penicillin for drug hypersensitivity; Levaquin for drug hypersensitivity. The following information was reported: PRURITUS (non-serious) with onset 14Dec2021, outcome "not recovered", described as "Intermittent itching. Occurs mostly at the spot but sometimes felt on face, neck, and other arm". Therapeutic measures were taken as a result of pruritus.  Additional Information: The patient had Intermittent itching. Occurs mostly at the spot but sometimes felt on face, neck, and other arm. Benadryl provides temporary relief. She had known allergies -SULFA, penicillin, LEVAQUIN. Other medical history included HBP, RA, Alpha Thalassemia. She did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a female patient of unknown age regarding herself. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX, (lot number, expiry date and route was unknown). On an unknown date, the patient experienced redness and a hard bump at the injections site. The outcome of the events were unknown. Additional information is not expected.
Patient returned on 06/23/2010 with complaint of lymph node swelling, dizziness, off/on chills/clammy, nauseousness. The upper left deltoid was red and painful to touch.
Vaccinee experienced possible Herpes Zoster (lt trunk); Seen in ER by employee hlth MD & treated w/ "Predizone" ?(PREDNISONE). Sx abated "x3 days w/inject." ER MD stated he felt this could be Engerix-B related.
1705 Complaint of tightness in chest.  No rash or swelling of tongue or lips.  Patient took Benadryl and used their inhaler.   BP: 162/96 O2: 97% P: 77 R: 20 1735 Patient states chest tightness is resolving.  150/82 O2: 97% R: 20
This spontaneous report was received from a registered nurse refers to a 4 year old patient. The patient's medical history and concurrent conditions were not reported. On 31-AUG-2015, the patient was vaccinated with an improperly stored VARIVAX (Merck) (lot # L010144, expiry date 24-MAR-2017). Concomitant medications were not reported. The outcome was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
16MAR94 vaxed w/DT 21MAR94 by phone call from mom informed that 18MAR93 lt arm swollen red to touch had dec swelling; 21MAR94 AM red blotchy hives noted w/itching; hives noted to lt forearms & shoulder has had no fever; referred to MD due;
Shot given at 10:30a-on 11/3/07. Arm started feeling "funny" about 6p.m. Took Advil. Had red rash at site of bandaid. Woke up next morning with hives on torso. Had a "reverse sunburn" in bra area.
DIED; This spontaneous report received from a patient via social media through company representative concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received influenza vaccine.  The patient previously received covid-19 vaccine ad26. cov2. s from an unspecified manufacturer (suspension for injection, route of admin, and batch number: Unknown, Expiry: Unknown) dose not reported, frequency 1 total, start therapy date were not reported for prophylactic vaccination (Dose number in series 1). It was unknown if the patient had any adverse events with covid-19 vaccine ad26. cov2. s dose number series 1. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: Unknown, Expiry: Unknown) dose not reported, frequency 1 total, start therapy date were not reported for prophylactic vaccination (Dose number in series 2). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  As per report "I was on a job working for people I've worked for before the man though not not young but in good health and spirt went to get a flue shot and the covid booster then died in 2 days after" (Dose number in series 2). On an unspecified date, the patient died from unknown cause of death. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of event died was fatal. This report was serious (Death).; Sender's Comments: V0: 20211263885-covid-19 vaccine ad26.cov2.s-Died. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Community member developed lightheadedness, vertigo on/off. during the post vaccination observation period. Was taken to ED with BP 141/92, HR 75 SpO2 100% room air. No further episodes and discharged to home.
Herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 70 year old male patient. No information was provided regarding medical history, concurrent conditions, concomitant medications, drug reactions or allergies. In July 2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, lot #, expiration date, route of administration and anatomical location were not provided) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced Herpes zoster. He was treated by a physician for the event. The outcome of the event herpes zoster was not reported. The reporter considered the event of herpes zoster to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Around 3:30 am on 4/17/21 typical vaccine side effects started: muscle aches, fatigue, temp. Symptoms continued through day time 4/17. Highest temp 102, took tylenol every 4 hours to help with fever and aches. At 9:30 pm began with continuous strong chest pain/shortness of breath. Nothing made it feel better. 9:45 PM Called after hour line of primary physician, who recommended going to ER. Left for ER at 10 PM. Chest pain had eased somewhat on the way to ER. Was seen at ER. Received EKG, lab work, CT scan, IV fluids and toradol. Chest pain was mild in ER and felt better by discharge around 3:30 AM.  Felt normal by 4/19/21 and returned to work. Have seen a few reports in news about myocarditis/pericarditis in males which seem to fit patients experience, so wanted to report the incident.
Aches, chills, fatigue for two days beginning the night of the shot. Entire arm ached for the first 24 hours and then only when injection site was touched for the next 4 days.
Have had terrible shoulder pain in left deltoid since date and time of shot. Have seen an orthopedic surgeon and had negative x-ray, however will be getting an MRI as shoulder pain has not subsided and on some days is worse than others.
This study case was received from the investigator on 12 November 2012. A 43-year-old female subject received the following vaccinations: On 21 June 2012 an injection of ACAM2000 (lot number not reported) and on 29 May 2012 an injection of TYPHIM VI, sanofi pasteur SA (lot number not reported) and ANTHRAX (manufacturer and lot number not reported). The subject had a past medical history of headaches and meningitis. On 03 July 2012, the subject was diagnosed with encephalitis following immunization procedures. Laboratory testing was not available. The outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Patient reported taking  prednisone 15 mg daily for past 2 weeks and next 4 weeks. Did not report immunocompromised. Gave 0.5 ml for 3rd Moderna shot. After review, patient is considered immunocompromised if 20 mg daily .
patient states that after receiving the vaccine he felt lightheaded and a little "woozy".  Patient states he always feels  a little lightheaded but wanted to make sure he was stable given he just received the vaccine. Patients vitals were stable, he was able to ambulate to his vehicle.
It is reported as a medication error due to administration of the vaccine after expiry (with no adverse event); Initial information was received on 08-APR-2022 regarding an unsolicited valid non-serious case received from a non-health care professional via call center.   This case involves an unknown age and unknown gender patient who experienced it is reported as a medication error due to administration of the vaccine after expiry (with no adverse event) while receiving vaccine HIB (PRP/T) vaccine [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a  dose of suspect HIB (PRP/T) vaccine (lot UJ357AAA and expiry- 26-JUL-2021) (strength, formulation, dose, route, batch number and expiry date: unknown) in unknown administration site for immunization.   On an unknown date the patient developed a non-serious "it is reported as a medication error due to administration of the vaccine after expiry (with no adverse event)" (expired product administered)  following the administration of HIB (PRP/T) vaccine. Action taken:  not applicable.  Action taken:  not applicable.  Outcome: unknown     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 the 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.
This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (103 degree Fahrenheit fever) in a female 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (103 degree Fahrenheit fever). At the time of the report, PYREXIA (103 degree Fahrenheit fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available):On an unknown date, Body temperature: 103 (High) 103 degree Fahrenheit.The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.Concomitant medication of the patient was not reported. No treatment information was provided by the reporter. This case was linked to MOD-2021-395802 (Patient Link). Reporter did not allow further contact.