chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hospitalized 11/21/2021; COVID-19 positive 11/19/2021; fully vaccinated  DATE OF ADMISSION:  11/21/2021 DATE OF DISCHARGE:  11/25/2021 HOSPITAL COURSE A 63-year-old patient presented to the ER with shortness of breath and increasing oxygen requirements.  See H and P for full details.  She was diagnosed with COVID infection and hypoxia with COPD exacerbation.  Her chest x-ray was clear.  She was started on Solu-Medrol and Remdesivir.  Completed 5 days Remdesivir.  Solu-Medrol slowly weaned during the hospitalization, and she received a total of 5 days of steroids.  At discharge, she was given prednisone 40 mg daily x5 additional days.  She has minimal wheezing on the day of discharge.  She does require 2 L of oxygen to maintain saturations above 90%.  The patient did receive 2 doses of Lasix with good diuresis.
experienced a sore arm after the first vaccination; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN IN EXTREMITY (experienced a sore arm after the first vaccination) in a 20-year-old male patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (experienced a sore arm after the first vaccination). At the time of the report, PAIN IN EXTREMITY (experienced a sore arm after the first vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2021-328621.
pleurisy; bilateral pleural effusions; bronchitis; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 39 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Mar2021 09:00 (Lot number: EN6205) at the age of 39 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Obesity" (unspecified if ongoing); "hypertension" (unspecified if ongoing). Concomitant medication(s) included: HYDROCHLOROTHIAZIDE; LISINOPRIL. Past drug history included: Clindamycin, reaction(s): "Known allergies: Clindamycin", notes: Known allergies: Clindamycin. Vaccination history included: Comirnaty (lot number: EL1283, Administration time: 09:0 AM, dose number: 1, Vaccine location: Left arm), administration date: 09Feb2021, when the patient was 39 years old, for Covid-19 immunization. The following information was reported: PLEURISY (medically significant) with onset 26Jul2021, outcome "not recovered", described as "pleurisy"; PLEURAL EFFUSION (medically significant) with onset 26Jul2021, outcome "not recovered", described as "bilateral pleural effusions"; BRONCHITIS (medically significant) with onset 26Jul2021, outcome "not recovered", described as "bronchitis". The events "pleurisy", "bilateral pleural effusions" and "bronchitis" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (01Dec2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of pleurisy, pleural effusion, bronchitis and included treatment with corticosteroids for 3 months. Clinical course: It was reported that the patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. The patient received the vaccine at hospital.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the  information in the case report, a possible causal relationship between the events Pain in extremity, Pleural effusion, Bronchitis and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Fever/had little bit of fever; This is a spontaneous report from a contactable consumer (parent) reported for her daughter. A 25-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 2 intramuscular, administered in left arm on 30Apr2021 12:00 (at the age of 25-year-old) (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient previously took first dose of BNT162B2 (lot number: unknown, vaccine location: Left arm intramuscularly) on 09Apr2021 for covid-19 immunisation. The patient previously experienced known allergies for egg white since ages. Family medical history includes psoriasis and dermatitis. On 01May2021 at 10:00 the patient experienced fever/had little bit of fever. Where the reporter mentioned that her daughter (patient) also received the vaccine and developed a fever afterwards. It was reported that there was no need of emergency room or physician office was required for the event. Patient received dose 1 vaccine within 4 weeks prior to the vaccination. It was also reported that the adverse events following prior vaccinations were none. Outcome of fever was recovering.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
a polyp in the sinuses; His ears started ringing but one ear was like the siren like it was almost unbearable; it was just ringing like a Siren going off in his ear;  got the second one and it came back full force again; He got something going on with his brain; This is a spontaneous report from a contactable consumer (patient's wife). A 49-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER8732 and Expiry date: Unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 03Apr2021 at 11:30 as single dose, dose 2 via an unspecified route of administration, administered in Arm Left on 24Apr2021 at 11:30 (Batch/Lot Number: EW0170; Expiration Date: 31Aug2021) as single dose for covid-19 immunization. The patients medical history was not reported. The patients concomitant medications were not reported. On an unspecified date in 2021 the patient experienced he got something going on with his brain, his ears started ringing but one ear was like the siren like it was almost unbearable; it was just ringing like a siren going off in his ear; got the second one and it came back full force again. The patient experienced both thing few days after he received both the first and the second vaccine. No other vaccine was administered. The patient was not still experiencing adverse events. The patient went and got an MRI because he got something going on with his brain and went to a neurologist but now it was gone, it went away. He just had a polyp in the sinuses but not any polyps in the sinuses on an unknown date in May2021. The patient underwent lab tests and procedures which included MRI (magnetic resonance imaging): unknown on an unknown date in May2021. The outcome of event polyp in the sinuses was unknown, the outcome of other events was recovered on an unknown date in 2021.  Information on Lot/Batch number is available; Further information has been requested.
BEGAN WITH SORENESS WITHIN A FEW HOURS. BECAME VERY TENDER TO TOUCH, SWOLLEN, RED, WARM TO THE TOUCH, ITCHED.
severe pain in left arm/neck/rib; severe pain in left arm/neck/rib; severe pain in left arm/neck/rib; Nausea; body aches; Cold and hot flashes with rigors; Cold and hot flashes with rigors; Cold and hot flashes with rigors; significantly warm to touch; Fatigue; lethargy; site of pain; This is a spontaneous report from a contactable nurse (patient). A 26-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL0142; expiration date: unknown), via an unspecified route of administration left arm on 04Jan2021 19:45 at a single dose for covid-19 immunization. Medical history included asthma and sulfa drug allergies. The patient was not diagnosed with Covid-19 prior to vaccination. Concomitant medication included albuterol [salbutamol] (ALBUTEROL), montelukast sodium (SINGULAIR) and vitamins nos (MULTIVITAMIN). The patient has not had other vaccine in four weeks. The patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EK5730; expiration date: unknown), via an unspecified route of administration left arm on 16Dec2020 06:30 AM at a single dose for covid-19 immunization which had no reaction other than slight tenderness at injection site. The patient received her vaccine in a hospital. The patient reported that within approximately 12 hours of second dose, she had severe pain in left arm/neck/rib. The pain was spasm-like and tight. She mentioned that the nausea was related to periods of pain. The patient had cold and hot flashes with rigors. The patient mentioned that she did not have access to thermometer, but significantly warm to touch. The patient added that she has fatigue /lethargy and body aches. It was reported that the systemic symptoms resolved within 24 hours while the site pain. Interventions done by the patient included acetaminophen, ibuprofen and ice pack to site of pain. The patient has been tested post vaccination, a nasal swab which was negative on 06Jan2021. The outcome of the events was recovered on Jan2021.
Ringing of the ears/Constant ringing of the ears; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ringing of the ears/Constant ringing of the ears) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939903, 002A21A and 025L20A) for COVID-19 vaccination.     The patient had not tested positive for Covid.  Concurrent medical conditions included Seasonal allergy.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TINNITUS (Ringing of the ears/Constant ringing of the ears). At the time of the report, TINNITUS (Ringing of the ears/Constant ringing of the ears) had not resolved.            No concomitant product was provided by the reporter. Ever since the first booster dose, patient had a constant ringing of the ears No treatment medication was provided.
This spontaneous report as received from a certified medical assistant (C.M.A.) refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 19-NOV-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # L017407, expiration date: 15-AUG-2015 or lot # L016428, expiration date: 30-JUL-2017 (it was not specified by the reporter which lot was administered) (dose, route of administration and location were not reported). No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Information has been received from a physician concerning a 15 year old female patient with no pertinent medical history or drug reactions/allergies who in 2010 "two years prior the second dose" was vaccinated with the first dose of GARDASIL (dose, route and lot # not provided, it was not administered in the physician's office) and on 29-MAR-2012 received the second dose of GARDASIL (dose and route not provided) (lot # 669794/1285AA) in the physician's office. Concomitant therapy included birth control pills (unspecified). The physician reported that when his receptionist called the patient's mother to schedule an appointment for the next dose of GARDASIL, the child's mother reported that her daughter had experienced an anaphylactic reaction following the vaccination on 29-MAR-2012, and had been admitted to the intensive care unit for six days. No laboratory tests were performed. On an unknown date, the patient recovered from the event. Anaphylactic reaction was considered to be immediately life-threatening by the reporting physician. A lot check has been initiated. Follow up information has been received from the physician concerning the patient who on 29-MAR-2012, was vaccinated with the second dose of GARDASIL intramuscularly in the right deltoid. The mother had agreed to forward all of her hospital records. Additional information has been requested.
pt recv vax APR96 & 2JAN97 pt varicella IgG ELISA was negative, 0.2;
Arm pain, swelling and redness from injection spot to the elbow. Arm feels very hot compared to the other area. This is my 5 covid shot and had no problems with previous injections. It has been 6 days since injection and the arm still feels hot and redness is still present to lesser extend. The swelling has also decreased.
got COVID positive; soreness of arm; headache; stuffy nose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness of arm), HEADACHE (headache), NASAL CONGESTION (stuffy nose) and COVID-19 (got COVID positive) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included NEBIVOLOL HYDROCHLORIDE (BYSTOLIC), HCTZ, LEVOTHYROXINE SODIUM (SYNTHROID), ROSUVASTATIN CALCIUM (CRESTOR), ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) and ZINC for an unknown indication.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced PAIN IN EXTREMITY (soreness of arm), HEADACHE (headache) and NASAL CONGESTION (stuffy nose). On 28-Jan-2021, the patient experienced COVID-19 (got COVID positive). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK, 2 tablets and PARACETAMOL, PHENYLEPHRINE HYDROCHLORIDE (THERAFLU DAYTIME) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (soreness of arm), HEADACHE (headache), NASAL CONGESTION (stuffy nose) and COVID-19 (got COVID positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jan-2021, SARS-CoV-2 test: Positive and Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Pt reported feeling that she was having trouble swallowing about 5 minutes after we gave her the moderna vaccine. I then gave her a 25 mg dose of benadryl and she did fine. The reaction stopped. Then I spoke with the pt about 6:30pm  and the throat problem had completely resolved, but she said that she was having left wrist pain and that that arm sort of felt heavy and she said it actually started while she was here but didn't say anything. I told her to take some tylenol and to watch this situation and report back if it continued to be a problem.
At around 9:30 I began getting chills. Body temperature through mouth thermometer: 97.9 degrees F.  Developed headache and fatigue over next half hour to an hour. Took my temperature again and it read 101.3. Took ibuprofen and rested. At around 2:30 am, my temperature was 100.0 F and my headache and fatigue felt better. I went to sleep.
Fatigue, watery eyes. Red rash around eyes, headaches, eye pain after flu vaccine sprayed in eyes, Pt was seen by 2 eye dr.
On Saturday she was in contact with her 3 year old grand daughter and then she tested positive for Covid-19; On Saturday she was in contact with her 3 year old grand daughter and then she tested positive for Covid-19; nausea; weakness; extreme fatigue; she had a sore throat and cough but she mentions that this is related to an allergy; she had a sore throat and cough but she mentions that this is related to an allergy; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A female patient of unspecified age (age 67,but units were not mentioned) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration on 04Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. She was asked on Thursday if in the last 14 days she was exposed to Covid-19, her granddaughter had Covid-19 and she was in contact with her on Saturday, so she answered yes. Patient received the first dose of the Pfizer-BioNtech Covid-19 vaccine on 04Mar2021, the next 3 days (until Sunday), experienced nausea, weakness and extreme fatigue, she had no fever or cold, she had a sore throat and cough but she mentions that this was related to an allergy. On Saturday she was in contact with her 3 year old grand daughter and then she tested positive for Covid-19. She like to know if she could go near her granddaughter and her family who's isolated for care giving reasons or if she has to wait until she receives the second dose of the vaccine (immunity after the first dose). she states she had never had a cold or flu, the CDC call her for blood samples because her AB are so strong and her protection last 6 months, she does not receive any medication. She would also like to know if after the first dose of the vaccine you need to quarantine as much as possible. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Headache, Arthralgia, Fever, loss of appetite, site pain/swelling/redness Narrative:
Pt describes a red rash, nonclustered, nonspreading, prutritic "pinhead" rash that presented very soon after vaccine administration. Pt contacted MD for treatment of rash and was given permethrin. Pt then contacted Dr. (dermatologist) for further treatment. Dermatologist prescribed premethrin (rule out scabies), methylpredinsolone dose pak and triamcinolone cream. The rash has not resolved.
PT HAD SOME REDNESS IN LARGE AREA BELOW INJECTION, DID NOT SHOW UP TIL RECENTLY, WAS JUST SORE BEFORE. NO LONGER SORE PER PT
NUMBNESS IN THE LEFT ARM; MILD HEADACHE; TROUBLE SLEEPING; URINATING VERY OFTEN, ALMOST EVERY HOUR; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. 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: 204AZ1A, expiry: UNKNOWN) dose was not reported, administered on 29-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-MAY-2021, the subject experienced trouble sleeping. On 29-MAY-2021, the subject experienced urinating very often, almost every hour. On an unspecified date, the subject experienced numbness in the left arm, and mild headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from trouble sleeping on 31-MAY-2021, urinating very often, almost every hour on 30-MAY-2021, and numbness in the left arm, and the outcome of mild headache was not reported. This report was non-serious.
Patient is a 77-year-old male with a history of coronary artery disease and cardiac arrhythmia which he currently wears a LifeVest for.  He also has a history of atrial fibrillation and is on Eliquis, hypertension, previous pancreatitis and kidney stones.  He presents to the emergency room by private auto in the company of a family friend secondary to increasing generalized weakness.  Patient was seen in the emergency room 2 days ago after he fell and injured his left shoulder and wrist and shoulder.  He has continued to get weaker at home and was having a hard time getting up and moving around today.  He also had an episode of urinary incontinence which is unusual for him.  Upon further questioning patient does admit to some dysuria with urination and hesitancy.  He denies fever or chills.  His only other complaint is pain to the left shoulder and wrist.  He is having a difficult time standing and walking around on his own which is new for him. Associated Symptoms: dysuria, fall, frequency, hesitancy, injury, joint pain, urgency, UTI symptoms, weakness
Genital herpes outbreaks; Increased genital herpes outbreaks after both doses; This case was reported by a nurse via call center representative and described the occurrence of genital herpes in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included genital herpes.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced genital herpes and condition aggravated. On an unknown date, the outcome of the genital herpes and condition aggravated were recovered/resolved.   It was unknown if the reporter considered the genital herpes and condition aggravated to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that the patient felt increased genital herpes outbreaks after receiving the dose of Shingrix vaccine. The reporter was unable to provide. Adverse event information other than gender. The reporter consented to follow up. For the tolerance of 2nd dose, refer case US2021AMR176145, reported by the same reporter. The case is linked to the case US2021AMR177309 and US2021AMR177313 reported by the same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR176145:Same reporter. US-GLAXOSMITHKLINE-US2021AMR177309:Same reporter. Pt2 - 1st dose. US-GLAXOSMITHKLINE-US2021AMR177313:Same reporter. Pt2 - 2nd dose.
have couple of friends who had it/suspected vaccination failure; have couple of friends who had it; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, 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.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the shingle shot and had shingles. The reporter had a couple of friends who got the vaccine and had shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. This case has been linked with US2021AMR241233, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR241233:same reporter
48 hours after vaccine, became crankly. 72 hours after vaccine, developed fever 104-105; noticed decline in activity. Seen in office on day 3 of fever (6 days after vaccines). CBC, blood/urine cultures done. Ceftriaxene give IM. Seen again 8 days after vaccines; still with fever > 104. CBC was normal. Blood/urine culture negative.