chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19, which include Antiviral from 20Apr2022 to 24Apr2022. Clinical course: The symptoms included Cold symptoms, coughing, sneezing, stuffy nose, runny nose, congestion from 29Apr2022 and were reported as recovering. No treatment was received for the symptoms. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Received vaccine 3/6/10. (L) back pain 3/11. Herpetic rash began at 3/12 in same dermatome. Saw pt 3/18/10 - confirmed clinical zoster and treated.
Pain, Edema, redness, limited range of motion to upper left arm.  Diagnosis of cellulitis and allergic reaction.  Bactrim twice a day, Tylenol #3 as needed for pain, Benadryl  Follow up with primary care physician in 48hours.
no adverse event; Healthcare provider reports an administration of an incomplete dose of VAQTA to a 2 year old patient on 16FEB2023. No further information provided. AE 02341822 filed. No additional AE reported. No PQC reported.; This spontaneous report has been received from a medical assistant concerning to a 2-years-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.  On 16-FEB-2023, the patient was vaccinated with an incomplete dose of Hepatitis A Vaccine, Inactivated (VAQTA) (strength, dose number, dose, route of administration and anatomical location was not provided (lot#: W036135, expiration date: 13-MAY-2024) (incomplete dose administered). No additional adverse event (AE) reported.
Information has been received from a nurse practitioner concerning a 17 year old female who in June 2008 (date discrepant), was vaccinated with the first dose of GARDASIL. On 07-DEC-2007 the patient vaccinated intramuscularly with the third 0.5 ml dose of GARDASIL. On 10-AUG-2008 the patient returned to the physician's office with numbness, tingling and weakness in her arms and fingers after receiving her third dose of GARDASIL. At the time of this report, the patient's symptoms persisted. The physician felt that the patient's condition was not a result of GARDASIL. Additional information has been requested.
I started feeling down in the dumps. I went to the doctor. What I was describing to her - prescribed a low dose anti-depressant medication. That is helping with the mood and I'm taking that still every day.  Joint pain - arthritis is what she tested me for but said I didn't have arthritis but I my wrists, knees, shoulders, ankles - all my joints hurt; hurts to get up off the couch or out of bed. No treatment for that. Some days are better and some days are worse. Ongoing pain. I drive a semi and some nights I'm driving and it feels like someone hit me with a hammer on my knee. Have to try to kick straighten out my legs and work it back and forth and finally it will go away. After that, it is just a kind of dull pain after that. I am to see the doctor again for a follow up to determine what next.
1/10/2010 noted throbbing in right arm 1-2 hours after injection. 1/7/2010 noted discomfort moved up into neck area and 1/8/2010 he noted discomfort and swelling under his right arm and into the R chest area with swelling. He says the right arm feels very heavy and tight and numb and tingly.
Sore arm; sweating; Feeling tired; Low grade fever; She slept a lot; her face was hot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), SOMNOLENCE (She slept a lot), FEELING HOT (her face was hot), HYPERHIDROSIS (sweating) and FATIGUE (Feeling tired) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: FLU. Concurrent medical conditions included Chronic kidney disease.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced SOMNOLENCE (She slept a lot), FEELING HOT (her face was hot), FATIGUE (Feeling tired) and PYREXIA (Low grade fever). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and HYPERHIDROSIS (sweating). At the time of the report, PAIN IN EXTREMITY (Sore arm), SOMNOLENCE (She slept a lot), FEELING HOT (her face was hot), HYPERHIDROSIS (sweating), FATIGUE (Feeling tired) and PYREXIA (Low grade fever) outcome was unknown.            patient was treated with Tylenol.   This case was linked to MOD-2021-090374 (Patient Link).
Pain in chest , headaches , body aches; Pain in chest , headaches , body aches; Pain in chest , headaches , body aches; Fatigue; Fever (101.8 °F); This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Pain in chest , headaches , body aches), PAIN (Pain in chest , headaches , body aches), HEADACHE (Pain in chest , headaches , body aches), FATIGUE (Fatigue) and PYREXIA (Fever (101.8 °F)) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced CHEST PAIN (Pain in chest , headaches , body aches), PAIN (Pain in chest , headaches , body aches), HEADACHE (Pain in chest , headaches , body aches), FATIGUE (Fatigue) and PYREXIA (Fever (101.8 °F)). At the time of the report, CHEST PAIN (Pain in chest , headaches , body aches), PAIN (Pain in chest , headaches , body aches), HEADACHE (Pain in chest , headaches , body aches), FATIGUE (Fatigue) and PYREXIA (Fever (101.8 °F)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.8 (High) f.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.  Based on the available current information and the temporal association of the use of the product and the start of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the available current information and the temporal association of the use of the product and the start of the events a causal relationship cannot be excluded.
He received immunizations this morning for DTaP, IPV, MMR, Hepatitis A, and Varicella. About five minutes after receiving the immunizations, he developed a rash around his eyes, and a cough. Mother says that he has continued to have some swelling around his eyes, with some rash. The cough has improved. He has a strong history of allergies in the past. He was just at the allergist's office two days ago, where they determined that he continues to have a milk allergy. He apparently had egg allergy in the past, but that is no longer the case. He eats about one egg every week. Mother says that, in the past, with milk allergy, he developed similar swelling of his eyelids.  It lasted only a few hours. I have recommended that he receive Benadryl, 12.5 milligrams every six hours. He was given a dose in the office at 1:00p.m. They are to observe him closely.  In the unlikely event that he gets worse, they are to take him to the emergency room, or call 911.
5 days later went to ER with severe chest pain. Determined it was a heart attack due to blood clot. Was in the hospital for 2 days. EKG, catheter to heart, cat scan, blood tests
Patient asked for a flu shot and indicated on the form at the pharmacy that he had never had a flu shot before. The injection was administered and patient left. When the technician went to post the information on the reporting site she found that the patient had received a flu shot two weeks before at another pharmacy.
REALLY GOT SICK; HIGH FEVER; This spontaneous report received from a consumer via a company representative concerned a 29 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced really got sick, and high fever. Laboratory data (dates unspecified) included: Body temperature high fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from really got sick, and high fever. This report was non-serious.
Chest and Back pain. Sneezing, sore throat, headache, nausea, chills and a swollen face.
346 (19%) measles non-immune (MNI) patients; Information has been received from the authors in the published literature article entitled as stated below, referring to 346 female patients (19%) of a group of 1813 individuals. Their medical history, concurrent conditions, and concomitant medications were not provided.  On unknown dates, the patients were vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (dose, route, anatomical location, lot #, and expiration date were not provided) for prophylaxis.  On an unspecified dates, the patients underwent serological screening where it was found that all patients were rubella immune; however, the 346 patients were also found to be measles non-immune (MNI) (measles antibody negative). Risk factors like public health insurance access and hispanic ethnicity increased the risk of patient's of being MNI.   At the time of reporting, the outcome of the event was unknown.  The reporting authors considered the event to be related to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown).  The authors concluded that in the absence of universal measles serologic screening recommendations, the risk factors identified could help guide clinicians in selective screening for those at risk of needing to take infection prevention precautions and postpartum measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) vaccination.  A copy of the published article is attached as further documentation of the patient's experience.
Reports sore arm after H1N1 shot next a.m. Has pain down her left arm into her hand.  Reports trouble writing, driving and cannot sleep on her left side.  Saw PMD who felt it was inflammation and to apply heat.  Pt reports no improvement to date.
On 10/2/13 approximately 9:00 AM patient complained of body aches, soreness at injection site, feeling feverish, and fatigue. Patient was sitting in chair at work station and didn't appear to be in severe distress. Nurse stated to this writer "two nurses were called to the patient's floor with an emergency cart. We offered to check patient. Patient declined services." Patient's supervisor notified this writer patient left work about 2:00 PM. At approximately 2:30 PM this writer contacted patient via phone. Patient stated she was being driven by her mother to her doctor's office as she was a type 1 diabetic and had recent problems with her insulin pump. She didn't think the flu shot caused her any untoward reactions. This writer gave client info about the flu shot including vaccine type, manufacture, route, site, and recommended her physician check with the CDC web site and/or call this writer for additional information. Patient verbalizes understanding to call this writer after the patient felt better for follow up. Patient given this writer's contact information. On 10/8/13 this writer contacted patient via phone call. The patient stated the following: "patient vomited 3-4 times and her BS was in the 50's. Her endocrinologist decreased the patient's insulin via insulin pump. Her endocrinologist said the fourth strain in the influenza vaccine was too strong for the patient and affected the patient's BS. Her endocrinologist recommended Ibuprofen 3-4 by mouth every day until pain decreased. The patient contacted Workman's Compensation on 10/3/13 and was sent to Workman's Compensation provider. Patient states the Workman's Compensation provider stated the following: "Patient had allergic reaction to the influenza shot, had an upper respiratory infection (URI), and the flu. Patient filled a prescription for an oral antibiotic she's to take three times a day which she is taking at present.
26MAY93 pt recvd vax for kindergarten @ 445PM; 27MAY93 started to devel red area around inject site; size of soft ball, hard, & hot to touch; pt very tired, no treatment done, when seen in clinic on 28MAY93 lt arm swollen;
About 5 to 10 minutes after receiving the Moderna vaccine, the patient reported a metallic taste in her mouth and a funny feeling on the tip of her tongue.  The patient took 25mg of generic Benadryl at this time.  She was monitored for a total of 30 minutes.  After this time she reported her symptoms were better and she had no additional symptoms.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The medical assistant reported that an expired dose of properly stored (wistar ra 27-3) M-M-R II lot # K008815 with expiration date 19-JUN-2106 was administered to an unspecified patient on 29-JUL-2106. No adverse reaction reported. No product quality complain twas involved. No further information was provided. Additional information has been requested.
Patient received incorrect dose of Moderna. She received vaccine for 6-11 yr old, instead of Moderna Bivalent booster. She had no adverse reactions.
Mother reported seizure like episode in PM on 03/10/2005, duration approximately 2-3 minutes.  Recovered without incident, 03/11/2005.  Better no problems, no temperature.  (Reported 03/11/2005)
Knot in arm of injection site, Hot to the touch, swelling of the injection site, redness of injection site, nausea, headache, chills, urinating every 20 - 30 minutes  Lost time out of work on 12-1-2021 due to symptoms
a nurse stated that an expired PROQUAD was administered to a patient.; This spontaneous report was received from a physician, referring to a patient of unknown age and gender. The patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies were not reported.     On 13-AUG-2020, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection (lot number S003862, which has been verified to be valid, expiration date reported and validated as 08-AUG-2020), as prophylaxis (expired product administered) (dose, dose number, vaccination scheme, route of administration, and anatomical site of vaccination were not provided). Additionally, the physician stated there were no previous temperature excursions.  At the time of reporting, the outcome of expired product administered was unknown.
One of one thousand that got Guillain Barre Syndrome; Infection or some kind and got into spine; This spontaneous case was received on 29-Aug-2023 from other non-health professional (consumer) (reference number SEQW23-01908) and concerned an elderly patient of unspecified age and gender. At the time of the reporting, the patient was 85 years old.  The patient's medical history and concomitant medications were not reported.   On an unspecified date, the patient was vaccinated with the influenza vaccine (brand not specified; dose, route of administration, anatomical location, and indication: not reported). The batch number was not reported.  On an unspecified date in 2007, an unknown amount of time after receiving the influenza vaccine, the patient had an infection which got into spine and it came down as Guillain Barre from the waist down and was admitted to the hospital. The patient lost ability to walk.  On an unspecified date in 2007, the patient had recovered from the event of Guillain-Barre syndrome and was discharged from the hospital. The patient stated that after rehab, was sent home in perfect state, and could walk without a cane, with no residual problems.  The reporter did not provide a causality assessment. The patient stated that was one of the 1 hundred thousand to get Guillain-Barre and was wondering to let it go and take the risk and get the flu again or take flu vaccine again this coming season. The patient hasn't had the flu vaccine since Guillain Barre, and before that had the flu shot every year and nothing happened.  The event of Guillain Barre syndrome was considered to be serious due to the seriousness criterion of hospitalization. Additionally, the event of Guillain Barre syndrome was considered to be medically significant by Physician within Seqirus' Pharmacovigilance Department.  Company comment: An 85-year-old patient had an infection that progressed to Guillain-Barre syndrome an unknown amount of time after receiving the influenza vaccine. The patient's medical history, concomitant drugs, and diagnostic findings were not provided. Due to lack of information and unclear temporal relationship, causality for the reported events (infection and Guillain-Barre syndrome) is unassessable.; Reporter's Comments: The patient stated that was one of the 1 hundred thousand to get Guillain-Barre and was wondering to let it go and take the risk and get the flu again or take flu vaccine again this coming season. The patient hasn't had the flu vaccine since Guillain Barre, and before that had the flu shot every year and nothing happened.; Sender's Comments: An 85-year-old patient had an infection that progressed to Guillain-Barre syndrome an unknown amount of time after receiving the influenza vaccine. The patient's medical history, concomitant drugs, and diagnostic findings were not provided. Due to lack of information and unclear temporal relationship, causality for the reported events (infection and Guillain-Barre syndrome) is unassessable.
approximately 2-3 hours after injection, unusual discomfort in the front left pelvic area. 8.5 hours after injection, left ear ringing and arm left deltoid soreness began. Woke up in the middle of the night with dizzyness. The next morning, dizzyness has subsided, left arm soreness and left ear ringing continues. Took 2x200mg ibuprofen.
25 minutes post vaccine- dizziness, visual changes `black spots` and nausea. Symptoms resolved after 35 minutes. Patient discharged and educated if any further symptoms occur or worsen to call 911 or go to ER.
Vaccine Lot # is associated with last flu season (2020-2021). Patient so far has reported no ADRs
Expired dose of HEPLISAV-B given to a patient; Initial Report Received on 23-Apr-2019   A pharmacist reported that his pharmacy sent an expired vial of Heplisav-B (hepatitis B vaccine) for hepatitis B immunization to a nursing facility and the nursing facility administered the medication to 55-year-old patient (gender and race not provided).  Relevant medical history included seizure disorder, depression, and history of deep vein thrombosis (DVT) in right lower leg. The patient had no known allergies.   Concomitant medications were not provided.   On 23-Apr-2019, a pharmacist reported that his pharmacy sent an expired vial of Heplisav-B (lot #1032912, expiration date 19-Mar-2019, NDC #43528000205) to a nursing facility on 11-Apr-2019. The nursing facility administered the medication to a patient. The pharmacist provided the patient's physician information. The pharmacist reported the information on behalf of the nursing facility to find out if there was an extended shelf-life for the product or what should be done since it (the vaccine) was given. The pharmacist gave permission to be contacted back via email or phone. No additional information was provided.   At the time of the report, there have been no adverse reactions reported to the expired dose of medication.   The reporter did not provide a seriousness assessment for the event.   Company comment:  The company assessed the event of expired product administered as non-serious. The event of expired product administered is unlisted per HEPLISAV-B USPI.; Sender's Comments: The company assessed the event of expired product administered as non-serious. The event of expired product administered is unlisted per HEPLISAV-B USPI.
Fever, nausea, swelling, body aches, headache, chills, fatigue, back ache.
Tongue swelling about an hour after. Lasted a few hours; This is a spontaneous report from a contactable consumer, the patient. A 42-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 arm left on 18May2021 at 12:30 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical history included essential oils allergy except lavender and penicillin allergy. The patient did not receive any concomitant medications. The patient previously took amoxicillin (MANUFACTURER UNKNOWN) and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18May2021 at 13:30, the patient experienced tongue swelling about an hour after. Lasted a few hours. Therapeutic measures were not taken as a result of this event. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  The clinical outcome of the event tongue swelling about an hour after. Lasted a few hours was recovered on 18May2021.   The batch/lot numbers for BNT162b2 were not provided and will be requested during follow up.
Developed a pink rash on the site of the injection approximately a week after the initial shot. It has grown in appearance over the past few days and is now about 5 inches by 3 inches in size. It is warm to touch but does not itch. I've had it for 5 days now and there is no sign of it beginning to disappear yet. So far each morning I check it and it is a little bit bigger. There is no pain at all.
injection site itchiness, persistent at least a week after injection. 12 days after shot, noticed red raised skin around the area of injection (like hives), and skin temperature of the area was significantly warmer than the rest of skin. Other than arm soreness the day after injeciton, no other side effects noticed.