chrisvoncsefalvay/vaers-outcomes huggingface dataset:
rash to his trunk, arms, legs, and face; Information has been received from a medical assistant of a physician referring to a 12 months old male patient. The patient has not known drug allergy (NKDA). The patient had no concomitant medication and pertinent medical history.   On 29-SEP-2021, the patient was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (dose 0.5 ml, lot# U015846, expiration date: 19-MAY-2021) subcutaneously for routine vaccination. No other vaccines were administered at that time. On 02-OCT-2021, the patient was seen at a urgent care facility for the rash he developed. The rash developed to his trunk, arms, legs, and face after vaccination with varicella virus vaccine live (Oka/Merck) (VARIVAX) and was prescribed oral diphenhydramine (BENADRYL). The physician was interested in varicella zoster virus (VZV) analysis by polymerase chain reaction (PCR) and wanted to send viral isolates. The outcome of rash to his trunk, arms, legs, and face was unknown.  The causality between the event and varicella virus vaccine live (Oka/Merck) (VARIVAX) was not provided.
cough; her husband was diagnosed with Covid and she has had a test (2021) she is in quarantine until the 7th; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 09Feb2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient was not reported. Medical history included her husband was diagnosed with Covid and she is in quarantine (2021). The patient's concomitant medications were not reported. The patient reported that she had cough and her husband was diagnosed with Covid and she has had a test (2021) she is in quarantine until the 7th (suspect covid-19) on an unspecified date in 2021. It was further reported that she had a cough but no fever. The patient added that her husband has had diarrhea and a cough and because he has dementia, she called the ambulance and they put him in the hospital, and he was diagnosed with Covid. He has been there since last Sunday (21Feb2021) and they want to release him today (01Mar2021). She has had a test (2021) but no results yet but she is in quarantine until the 7th (07Mar2021) and they are supposed to get their second vaccine on 05Mar2021. She needs to reschedule her appointment. The outcome of the events was unknown.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with a dose of VARIVAX (Merck) (route, lot # and expiration date were not provided). On an unknown date, an unspecified number of patients received VARIVAX (Merck) exposed to minus 14 degrees C for 6 hours. No adverse symptoms were reported. At the time of the report, the patients' status was unknown. This is one of several reports received from the same source. Additional information has been requested.
Passed out; Unsteady; Slurring her words; Fell into a deep sleep; Tingly in her upper right arm; Feels like equilibrium is off; Legs feel heavy; Fatigue; A spontaneous report was received from a consumer who was also a 71-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced passing out (loss of consciousness), unsteadiness (gait disturbance), slurring words (dysarthria), fell into a deep sleep (hypersomnia), tingly feeling in her upper right arm (paraesthesia), felt like equilibrium was off (balance disorder), legs felt heavy (limb discomfort), and fatigue.  The patient's medical history included epilepsy.  Concomitant products known to have been used by the patient, within two weeks prior to the event, included clonazepam.  On 03 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  The patient was slurring her words and fell into a deep sleep.  It took three individuals to wake her up.  The patient wondered if she passed out.  She felt tingly in her upper right arm and it felt like her equilibrium was off, and legs were heavy.  The patient was very fatigued.    Treatments of these events were not provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, passing out, unsteadiness, slurring words, fell into a deep sleep, tingly feeling in her upper right arm, felt like equilibrium was off, legs felt heavy and fatigue, was unknown.; Reporter's Comments: This case concerns a 71 year old female subject, with history of epilepsy, who experienced a serious unexpected event of loss of consciousness after first dose of mRNA1273 (Lot# unknown). Concomitant medication included clonazepam. Very limited information has been provided at this time. Further information has been requested.
anaphylaxis, hives, hypotension, tachycardia, facial swelling
january 19th during lunch, experienced a slurring of speech, left eye and left side of mouth droop. unable to hold in fluids. went to ED, stated all the tests were normal. air flighted to higher level of care facility for neurology. MRI/ CT negative. work up for stroke unfounded. 1/26 ENT visit- no definitive diagnosis. treatment with levaquin and steroids.
pt devel rash under rt eye & that eye was red & swollen; Sat PM 22OCT94 p/being vaxed 17OCT94; pt was taken to ER; 23OCT94 mom states MD denied connection between immunation & red swollen eye
Constant heavy sweating, going on 4 days after vaccine. Sweating happens regardless of fever. Tylenol helps the fever but the sweating remains.
Full body numbness, able to feel pressure, no pain. Dizziness, burning rush sensations scattered settled in right side of head neck chest arm and back, feel of passing out with standing up or sitting; Full body numbness, able to feel pressure, no pain. Dizziness, burning rush sensations scattered settled in right side of head neck chest arm and back, feel of passing out with standing up or sitting; Full body numbness, able to feel pressure, no pain. Dizziness, burning rush sensations scattered settled in right side of head neck chest arm and back, feel of passing out with standing up or sitting; Full body numbness, able to feel pressure, no pain. Dizziness, burning rush sensations scattered settled in right side of head neck chest arm and back, feel of passing out with standing up or sitting; This is a spontaneous report from a contactable Other HCP.  A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscularly on 28Dec2020 10:30 at single dose for covid-19 immunisation. Vaccine location: Left arm, dose number: 1, facility type vaccine: hospital. Medical history included viral asthma, hypertension, mild depression, anaphylaxis to Bee Stings, vertebral artery dissection with brainstem injury and covid-19 (If covid prior vaccination: Yes). Concomitant medication included acetylsalicylic acid (ASPRIN), metoprolol (METOPROLOL), omeprazole (PROTONIX [OMEPRAZOLE]), hydrochlorothiazide (HYDROCHLOROTHIAZIDE), bupropion hydrochloride (WELLBUTRIN). The patient previously took erythromycin and experienced drug hypersensitivity and fentanyl and experienced drug hypersensitivity. On 11Jan2021 02:00 the patient developed "full body numbness, able to feel pressure, no pain. Dizziness, burning rush sensations scattered settled in right side of head neck chest arm and back, feel of passing out with standing up or sitting up". The patient was taken to emergency room (ER) /department or urgent care. In the ER all labs and CT with and without contrast clear, but was unable to find any other reason for the event. No treatment received. The events outcome is recovering. The action taken was not applicable.
Patient's wife notified the pharmacy of this adverse reaction on 9/27/19. Patient's wife noticed that her husband was dizzy and had a sense of feeling off balance. Patient's wife also reported that her husband was experiencing a very rapid heart rate. Patient eventually fell down and was in a fetal position per the wife. The wife then contacted emergency services. Patient was placed on the intensive care unit for one day for treatment of a pulmonary embolism that had occurred. Patient was appropriately treated and sent home on 9/27/19.
This spontaneous report was received from a registered nurse (R.N.) refers to multiple unspecified number of patients of unspecified age and gender. Medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored oral, ROTATEQ (Lot # L004453 and exp. 27-MAY-2016; lot # K020183 and exp. 25-JUN-2016) (dose, site and route of administration was not reported). No adverse events were experienced. The outcome of the reported events was unknown. No product quality complaint (PQC) was filed. No further information was provided. This is one of several reports from the same reporter. Additional information has been requested.
Pt developed pruritis, erythematous rash and SOB approx 10-20 min after administration. SpO2 remained >94%.
Post vax the patient had swelling at the injection site and severe pain to the elbow. The patient was treated with Solu Medrol and given pain medication. On 10/19/2001 the patient states her arm is better.
HORRIBLE CHEST PAIN; BODY ACHES; CONSTANT NEED TO STRETCH OVERNIGHT; PAIN IN GROIN AREA; PAIN IN NIBBLES; PAIN ON BOTH SHOULDERS; NO ENERGY; TEMPERATURE; HEADACHE; This spontaneous report received from a consumer concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced horrible chest pain, body aches, constant need to stretch overnight, pain in groin area, pain in nibbles, pain on both shoulders, no energy, temperature, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, horrible chest pain, temperature, pain on both shoulders, body aches, constant need to stretch overnight, no energy, pain in groin area and pain in nibbles was not reported. This report was non-serious. This case, from the same reporter is linked to 20210858507.
11/21/2022 Nasal Sore throat and fever peaking at 101.9 and chills.  Tested with an At HOME COVID-19 test, Positive.  11/22 televisit with doctor.  Doctor advised of isolation and treating symptomatically.  Symptoms were consistent for about 6 days and then stopped suddenly.  Experienced Brain Fog for about 2 weeks after that.
Red swelling; Red swelling; Injection in left arm but cannot assure it was intramuscular; A spontaneous report was received from a consumer who is a 60-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and got injection in left arm but cannot assure it was intramuscular, red and swelling (injection site erythema and injection site swelling).   The patient's medical history was not provided. No concomitant medications were reported.  On 11 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) in the left arm for prophylaxis of COVID-19 infection.   On 11 Jan 2021, after the first dose of vaccine, the patient confirmed that she was fine but had a small pinhead were the vaccine was injected and was not sure if she got the injection via intramuscularly in the left arm. On 20 Jan 2021, when patient woke up, she found with red swelling that continued to grow at the time of this report. Treatment for the event included unspecified antibiotic.   Action taken with mRNA-1273 in response to the events were not provided.   The outcome of the events, injection in left arm but cannot assure it was intramuscular was considered resolved on 11 Jan 2021. The outcome of events red swelling was considered not resolved and was continuing at the time o this report.; Reporter's Comments: This case concerns a 60-year-old female with a NS unexpected event of Incorrect route of product administration and NS expected events of Injection site erythema and Injection site swelling.  The expected events occurred 10 days after first dose mRNA-1273 (lot # unknown). Treatment included an antibiotic. Based on current available information and temporal association between the use of the product and the start date of the associated adverse events, a causal relationship cannot be excluded.
Patient became dizzy immediately after receiving vaccine. Blood pressure systolic 99. Was unable to stand due to fear of potential syncope. Gradually recovered with cold compresses and drinking water and full-sugar soda.
Pt vomited after administration, pt also was sweating and shaky, pt has previously fainted upon other vaccine administrations.
TERRIBLE HEADACHE; DIZZINESS AND LIGHTHEADEDNESS; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's past medical history included colonoscopy, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, administered on 21-MAR-2021 to left arm for prophylactic vaccination. Concomitant medications included apixaban for blood thinner. On OCT-2020, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On 2021, the subject experienced dizziness and lightheadedness. On MAR-2021, the subject experienced terrible headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness and lightheadedness, and terrible headache on 2021. This report was non-serious.
Received only the liquid meningococcal CWY-135 portion; Inappropriate preparation of medication; This case was reported by a nurse via call center representative and described the occurrence of incorrect dose administered in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA521A, expiry date 31st October 2022) for prophylaxis.   On 12th August 2021, the patient received Menveo. On 12th August 2021, unknown after receiving Menveo, the patient experienced incorrect dose administered and inappropriate preparation of medication. On an unknown date, the outcome of the incorrect dose administered and inappropriate preparation of medication were unknown.  Additional details were provided as follows: The registered nurse reported that, a medical assistant administered Menveo vaccine to the patient without reconstituting vaccine with meningoccocal A lyophilized portion prior to administration, which led to inappropriate preparation of medication The patient received only the liquid meningococcal CWY-135 portion of the vaccine, which led to incorrect dose administered. The reporter provided permission for follow up.
Patient received vaccine, ~10 minutes later she reported feeling dizzy & lightheaded. She was given a glass of water and was helped into a reclining position with her head below her feet.  Her Blood Pressure was 126/89, pulse 78 approximately 10 minutes after onset of symptoms.  She remained in the reclining position for approximately 20 minutes.  She reported feeling "OK" about 30-35 minutes after vaccine administration.
Information has been received from a physician and a consumer concerning a 30 year old female with multiple sclerosis (diagnosed in January 2010), insomnia, diverticulitis, migraine, chronic obstructive pulmonary disease and tobacco user, with no allergies or hypersensitivities. In June the patient had a flare up of diverticulitis which led to her hospitalization. The patient was treated with 5 days of antibiotics and noticed an increased in the occurrence of diverticulitis which may require surgery. The doctor was unsure if the diverticulitis was related to multiple sclerosis. The patient also reported questionable diabetes, an increased in bacterial growth on the back of her tongue, leg numbness, leg tingling, headaches, site reactions which included stinging and flu like symptoms. The patient massaged her site reactions and pre-medicated with MOTRIN 600 mg. On 07-SEP-2010, the patient was vaccinated with PNEUMOVAX 23. Concomitant therapy included REBIF, hormonal contraceptives (unspecified) and VALIUM. Subsequently the patient developed symptoms around the injection site including small raised red bump that became larger, red painful, and hot to touch. The patient then developed fever and chills and her hands became cold. The patient administered TYLENOL and her temperature went down, but spiked back up. On 09-SEP-2010, the patient developed right arm cellulitis and constitutional signs to the right shoulder following PNEUMOVAX 23 and was hospitalized. The patient had a temperature of 103, a chest x-ray was normal and the patient was treated with steroids and was discharged on prednisone and AVELOX. Therapy with REBIF was continued. On 11-SEP-2010, the patient's right arm cellulitis after vaccination with PNEUMOVAX 23 had resolved. The flare of diverticulitis had also resolved and the status of questionable diabetes flu like symptoms were not reported. The patient was recovering from headaches, leg numbness and leg tingling and had not recovering from injection site reactions and increased bacterial growth on the back of her tongue. The physician assessed the right arm cellulitis after vaccination with PNEUMOVAX 23 as not related to therapy with REBIF. On 16-SEP-2010, a recent colonoscopy showed just a few pouches of diverticulitis. Additional information has been requested.
No additional AEs; expired dose of RECOMBIVAX was administered.; This spontaneous report was received from a Medical Assistant and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies was provided.    On 03-FEB-2023, the patient was vaccinated with an expired dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) lot # U019135 with expiration date of 22-NOV-2022 (expired product administered), 0.5 milliliter, intramuscularly for prophylaxis.   No additional event reported.   This is one of several reports received from the same source.
Significant fatigue ~24 hours after vaccination. Muscle aches, joint pain, fatigue ~48 hours after vaccine. No fever noticed.
Upper arm is extremely tender; Upper arm is extremely painful; cannot lift it above shoulder height due to pain; This is a spontaneous report from a contactable consumer (patient). A 38-years-old male patient received first dose of bnt162b2 (Pfizer BioNTech, formulation: solution for injection, Lot Number: EW0167), via an unspecified route of administration, administered in right arm on 20May2021 11:30 (at the age of 38-years-old) as single dose for COVID-19 immunisation. Medical history included ongoing SSRI discontinuation syndrome which would come back whenever he was sick and apparently also from the vaccine and ongoing electric brain zaps when he would get sick or have a temperature ever since he was a child and was taken off of paroxetine cold turkey which induced electric brain zaps and they went away at that time but continued having them lifelong whenever he would get sick, and also in response to this vaccine which felt like a jolt of electricity in the brain. The patient had no other vaccine in four weeks. The patient did not have COVID prior vaccination. The patient was not COVID tested post vaccination. The patient had no known allergies. Concomitant medications included lorazepam; diazepam; paroxetine and bisoprolol. The patient previously took paroxetine. On 21May2021 at 01:00, the patient experienced upper arm was extremely tender, painful and could not lift it above shoulder height due to pain. It was unknown if the patient received treatment for the events. Outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Patient reports on 04-19-21 while at Site with her two children who are receiving their Covid vaccines that she has had Left Arm pain following the injection on 04-06-21. Reports the pain resolved without treatment after three days, and then returned again.
REDNESS ITCHING AT SITE STILL PERSISTING ON 9/20/2016.
Severe itching on chest, arms, neck and hands; mild rash; diarrhea. OTC topical BENADRYL and oral BENADRYL.
This case was reported by a pharmacist via call center representative and described the occurrence of fatigue in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included open heart surgery and arm operation. Previously administered products included Shingles vaccine (received in July 2010) and SHINGRIX (1st dose received on 18 July 2018, refer case US2019GSK065308.). Concomitant products included SHINGRIX. On 8th January 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fatigue. On an unknown date, the outcome of the fatigue was unknown. It was unknown if the reporter considered the fatigue to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in her right arm. The patient described that it was zapping her strength and energy. The patient provided to follow up which her nurse practitioner. This case has been linked with the case US2019025070, (case) reported by the same reporter and same patient.
pt recvd vax; pt devel itching on entire body; tx w/ aveeno bath; symptoms recurred w/ 2nd & 3rd dose of vax;
A nurse reported the occurrence of a rash in a 23-year-old female who was vaccinated with hepatitis A inactivated and hepatitis B recombinant vaccine (Twinrix) for prophylaxis. The pt's medical history included asthma and allergies to grass and dust. The pt had no adverse experiences following receipt of previous immunizations. Concurrent medications included albuterol as needed. On 01/29/2003 the pt received her first injection of Twinrix (lot HAB235A4). On that date, she also received an injection of influenza virus vaccine (manufacturer unknown). Four days post-immunization, on 02/02/2003, the pt developed an itchy rash on her abdomen and back. The rash and itching resolved after approximately one week. The Twinrix immunization series was delayed.
ringing in the ears (tinnitus); This case was reported by a consumer and described the occurrence of tinnitus in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included tinnitus.   On 12th July 2020, the patient received the 1st dose of Shingrix. In July 2020, an unknown time after receiving Shingrix, the patient experienced tinnitus. On an unknown date, the outcome of the tinnitus was unknown.   It was unknown if the reporter considered the tinnitus to be related to Shingrix.  Additional details were provided as follows: The patient stated that, there were days when his ears ring for 24 hours straight and there was times where could had a day with no ringing.  The patient did see two ENT doctors and there was nothing wrong with his ears or eardrums.  The patient received Shingrix and 12 hours after developed ringing in the ears tinnitus and never had that prior to receiving the vaccine.  He stated, it was just ironic that he lived 61 years of life without ringing in ears until 12 hours after received the vaccine and did had the second vaccine in December hoping it would reverse it, but it did not. The patient felt should let know this happened to see if there are any suggestions GSK might had.