chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt was admitted on 6/15/21 with c/o sudden palpitations and was admitted with rapid atrial fibrillation and an NSTEMI. Her rate was difficult to control despite increasing her metoprolol to 100mg/d so diltiazem was added. Her rate was better controlled and she was discharged home on 6/22/21 to follow up with cardiology.
pt slept more than usual day of vax following day 9AUG per mom cried all day only quiet for about 1 hr; gave APAP q 4 hrs-no fever;
BURNING SENSATION ALL OVER BODY; RED EYES; HOT EYES; BODY ACHE; HEADACHE; NAUSEA; This spontaneous report received from a consumer concerned a 34 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 not reported, batch number: 202A218, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 08-APR-2021, the subject experienced burning sensation all over body. On 08-APR-2021, the subject experienced red eyes. On 08-APR-2021, the subject experienced hot eyes. On 08-APR-2021, the subject experienced body ache. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from burning sensation all over body, headache, red eyes, body ache, nausea, and hot eyes. This report was non-serious.
Itchy rash on left forearm, followed a week later by a rash on my right forearm, also itchy.  Then a few days later the left forearm showed the rash area was expanding and turning black and blue.  Muscle aches in bicep and forearm area of both arms, and more severe in left arm.
Sick and chills  and bodyache night of vaccine, horrible headache lasting for 2 days. On the third day, another headache.  On the fourth day, mild headache. 5th day bad headache and that afternoon started tongue swelling and right gland in throat is sore/swollen. Hurts to swallow.
mom noticed pt's eyes puffy (swelling shut) about 4PM; face seemed swollen; no other s/s; pt cried alot between 7PM--8PM then went to sleep & slept till 4AM; while sleeping, pt made snoring noises & would cry in sleep;
Mom state pt had hives on face & buttocks since 29JUN91; DPH effective temporarily; No other sx;
Information has been received from a physician concerning an about 3 year old male who in late 2008 was vaccinated with the second dose of VARIVAX (Merck) (LOT # not reported). In January 2009, the patient had shingles on his hand and forearm. There was no diagnosis nor lab study performed. Unspecified medical attention was sought. On an unspecified date, the patient recovered from shingles. Additional information has been requested.
COVID breakthrough case. Patient presented to the Emergency Department on 11/7/21 with altered mental status, fatigue, and fever. He tested positive for COVID on 11/8/2021.
pt stated that later the day after receiving the vax that he started having pain on the left side of his head.  The pain went from jaw to temple.  He wasn't able to speak for 3 days.  On 2/17/2021 he went to the hospital.  They thought he may have Bell's Palsy so the they did a XRAY and CT.  They were not able to find anything other than facial swelling so he was discharged and told to come back if he did not get better and they would make him an appt w/ an ENT.  He started taking Aleve.  He no longer has constant pain but his mouth still hurts when he opens it.  He will contact his PCP to let her know what happened and to let her know that he will not be taking his 2nd covid vax dose.
This spontaneous report was received from a physician regarding a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX23 (lot # 0491AE, expiry and route not reported). No concomitant medications were reported. On an unknown date, the patient experienced local swelling at injection site, malaise and fever. It was unspecified if the patient had sought medical attention. No treatment information was reported. The outcome of local swelling at injection site, malaise and fever was unknown. This one of several reports received from the same reporter. Additional information has been requested.
vomiting; has been vomiting regularly for 3 hours, with intermittent periods of sleep/rest. 5/14/2010 Follow up: The patient is my daughter. In addition to the vomiting and diarrhea listed in the report, she also developed a full body rash all over her trunk. It did not seem to bother her, and went away about 36 hours later. The vomitin seems to have subsided this morning, or about 2 days after it started. The diarrhea is not over. She hasn't had solid food in 2 full days and just started eating and drinking water again. She was very lethargic and cranky all day yesterday and all day today untill about 3 in the afternoon, when I developed symptoms of vomiting and diarrhea. Finally she developed an eye infection in her right eye. It was irritated and itchy yesterday, and she woke up this morning with it crusted over with green goo. Her left eye is also excreting some pus, but not nearly as much as right eye, and it is not pink like the right eye. This just seems to be getting worse.
I did not report this to my doctor, I just assumed it was a reaction to the shot.  I had a rash from the vaccine site for about three inches and it was itchy.  After a shower it was bright red. Lasted about 7 days then went away.   Saw a report about this so I thought I would fill this out because it was exactly as stated in the report.
Cellulitis at site of injection. Seen in ER, injection of rocephin given and finished oral cephalexin. No further complications.
This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. Information regarding relevant medical history, concurrent condition and concomitant medications were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored VARIVAX (lot # M000998 with expiration date 07-JAN-2018, lot # M006156 with expiration date 05-FEB-2018, lot # M010482 with expiration date 01-MAR-2018, lot # M009765 with expiration date 23-FEB-2018, lot # M019643 with expiration date 20-APR-2018, dose and route not reported). No adverse effects were reported. The patients would continue vaccination with VARIVAX. This is one of two reports received from the same source. Additional information has been requested.
Contracted new strain of covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Contracted new strain of covid) in an adult female 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Contracted new strain of covid). At the time of the report, COVID-19 (Contracted new strain of covid) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case involves a patient of age in 20's. Concomitant product use was not provided by the reporter.   No treatment information was provided.   Reporter did not allow further contact
1st Vaccine 1/14/21; 2nd Dose Vaccine 2/2/21; developed nausea, elevated temp, chills, body aches, and severe headache 2/3/21.
Since shot last Thursday April 29 at 930 am I cannot sleep at all and have a hard time breathing. Body will not let me fall asleep. I get a rush of nervous or anxious energy and hot flashes
Patient complained of swelling and redness of two fingers on her right hand. She also vomited four times and felt very tired. She came into the office on 11/18/2009 for a recheck. Dr. advised her to take Benadryl and to advance with clear liquids as tolerated. Mom called back later that day to report that her lips were slighly swollen. Instructed to give Benadryl ASAP and follow up if no improvement.
patients administered Moderna vaccine while temperature excursion assessment was ongoing; patients administered Moderna vaccine while temperature excursion assessment was ongoing; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing) and PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered Moderna vaccine while temperature excursion assessment was ongoing) in a 67-year-old female 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .27 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing) and PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered Moderna vaccine while temperature excursion assessment was ongoing). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing) and PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered Moderna vaccine while temperature excursion assessment was ongoing) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was reported. No concomitant medication was reported.
Received Zostavax on 3/26/07. Pt called back c/o red swollen arm. 3/28 pt examined lg area of erythema swelling, warmth spreading distally from L posterior upperarm, tiny vesicular lesions centrally approx 3 cm from injection site Diag: robust reaction vs cellulitis
fever of 101°F; I have chills; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever of 101°F) and CHILLS (I have chills) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced PYREXIA (fever of 101°F) and CHILLS (I have chills). At the time of the report, PYREXIA (fever of 101°F) and CHILLS (I have chills) outcome was unknown. Not Provided          relevant concomitant products usage were not reported by the reporter.  Treatment details not included.
Patient c/o pain in (R) deltoid area is warm to touch, reddened, swollen with induration. Cold pack applied. Ibuprofen administered.
imbalance issue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 12-year-old female patient received BNT162b2 (BNT162B2), in Dec2021 as dose 2, single (Lot number: 30145BA) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Lot number: EW0191), administration date: Sep2021, when the patient was 12 years old, for COVID-19 immunization. The following information was reported: BALANCE DISORDER (non-serious) with onset Dec2021, outcome "not recovered", described as "imbalance issue". The event "imbalance issue" required physician office visit.  Additional information: Caregiver for 12 year old daughter vaccinated in September. Caller stated that in December, daughter began having "imbalance" issues after running or strenuous activity. Daughter's HCP did not think there was a connection, but mother was reaching out to find any information available about other cases or to receive medical suggestions. Reporter stated, "she was speaking to her cousin and he suggested I contact Pfizer so my daughter had the vaccine for the corona virus both of them in September and December until now she had an imbalance issue. Now, doctor can't seem to figure out what's wrong with issue, it was perfectly healthy before. So she was sure if you have see patient with this type of situation he has mentioned that some times the pharmaceutical company have medical people that you speak to when you have symptom that could to could not be related to you know something like that that why I am calling I don't know what department it was. Reporter was informed about role of Pfizer drug safety department and Pfizer medical information department.  No follow-up attempts are possible. No further information is expected.
Vaccinated on 1/11/21 and on 1/18/21 I developed redness, warmth, and itchiness at the vaccine site, worsened the next day, applied topically hydrocortisone cream and redness and itchiness decreased 1/20/21
Patient received Pfizer COVID vaccine from a different Vendor on 1/26/2021 and 1/29/2021.  Patient received 3rd dose Pfizer vaccine from us at Physicians on 8/7/2021 at Mall location.  Investigation confirmed a regulatory authority had a different address listed for patient.
Adverse event reported to our office on 12/13/12. Patient reported redness & swelling in the right arm following the injection. As of 12/13/12, patient states swelling, redness improved but she has pains in right shoulder when raising her arm & reaching behind her, occasional numbness in finger tips. (+) tenderness with abduction & external rotation of right shoulder after (2 weeks) immunization. On 12/13/12, no point tenderness or subcu masses on palpation of (R) deltoid area. Not better after 4 days of ALEVE 2 po bid.
This spontaneous report was received from a registered nurse refers to an unspecified patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were unspecified. On an unknown date, the patients were vaccinated with improperly stored PEDVAXHIB, lot # L004738, expiry date 10-NOV-2017; K019700, expiry date 16-JUL-2017; L006546, expiry date 27-NOV-2017; K025006, expiry date 22-JUL-2017. No adverse effects reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. No additional information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Patient with fever, diarrhea and left hip pain beginning 7 days after vaccination and ongoing x 5 weeks. Patient with extensive evaluation without clear etiology of fever of unknown origin and diarrhea.
103F temperature for a few hours; Dose number=3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An elderly patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious), outcome "recovered", described as "103F temperature for a few hours"; IMMUNISATION (non-serious), outcome "unknown", described as "Dose number=3". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
A report has been received from a Health Professional concerning a 4 year old, male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT (Intranasal) started on 14-Oct-2013. The patient experienced patient tested positive for flu after getting FLUMIST which started on 16-Dec-2013. At the time of reporting, the event of patient tested positive for flu after getting FLUMIST was ongoing. The report was considered to be non-serious.
First red blotch approx. 7 hours after shot. Some pain, no itching. Then larger "welt"  (about 2'x3') developed lasting several days. Finally diminishing to light red spot about the size of half dollar. Then skin pealed in area of welt.. Slight redness still persists after 12 days.
After child received Hepatitis vaccine he went to front area. At 2:07 he was standing outside of restroom in front lobby waiting for his mother.  He fell and hit head on floor. Child was holding hands stiff and shaking. Security called for help for a nurse. EMT and Childs vital signs taken at 2:09pm B/P 96/67, blood sugar 91, At 2:11pm B/P 89/47, pulse 60, 2:14 pm O2sats 98%. 2:15pm EMT arrived. AT 2:20 pm Child and mother left with EMT.
pt recv vax 25APR97 & pt devel varicella;mom reported that daughter has had over 100 lesions that average two a day since the rxn & may last 4 days then disappear but then they come back;described as red w/spot in middle, liquid bump. Information has been received from the mother of a 13-month-old. Caucasian female with Down's Syndrome, an unspecified heart defect and scabies who on 25APR97 at 11:00AM was vaccinated with the first dose of VARIVAX SC in the right arm. Concomitant therapy included vitamins. Approximately forty day's post-vaccination, on 04-JUN-1997, the patient developed a rash. The mother reported that her daughter has had "over one hundred lesions all over her body which average two a day since the reaction and may last four days then disappear but then they come back to the same areas  as before. " The lesions were described as "red with a spot in the middle, liquid bump, very tiny, nont dig." It was reported that the rash was "originally thought to be vaccine related, but it was likely due to scabies." Subsequently, the patient recovered with ELIMITE. This is an amended report. The age now reads 13 months instead of 12 month. The adverse event onset date now reads 04?-JUN-1997 instead of 05/??/97 and the narritive was updated accordingly. Vaccine administration information was included.
Chest pains.  It's a constant pain stemming from my heart that has been going on since about 2 hours after the vaccine.
Headache, Myalgia, Arthralgia, Fever,  CoughWheeze, fatigue, chills, mailaise Narrative:
Patient had her 1st Moderna on 05/08/21 within 10 minutes of the injection she experienced dizziness and nausea, she received medical care there for her temp and BP and they had her lay down for 45 minutes before releasing her and the symptoms of dizziness was all day. The nausea subsided when removing her mask.  She said other peoples movement made her dizziness, she had shiver and chills that she could not control. When she got home her mouth was numb and tingly but did not go into her throat.  She felt her jaw felt numb and she could not feel her teeth. She also thought she was slurring her words. Patient currently in contact with her PCP office as she was advised to go back to ED as some of her symptoms have returned and she is now experiencing chest pressure on 5/10/21.
Child received vaccine on 3/23/01 and on 3/24/01 had red, blotchy rash at injection site: Hives which continued to spread hives systemically. No shortness of breath or stridor.
This spontaneous report was received from a physician who is the patient via a company representative. The patient was male and was around 60 plus years of age. The pertinent medical history was none. On 27-AUG-2015, the patient was vaccinated with PNEUMOVAX 23 (1 vial) (route and lot details unavailable) in the arm. The concomitant medication was not reported. On 28-AUG-2015 (also reported as the next day), the arm in which he received the vaccine was sore, he had achiness all over his body and he generally did not felt well. It was unspecified who administered the vaccine. The patient did not seek any medical attention and no treatment was rendered for the event. The action taken with PNEUMOVAX 23 was not applicable. The outcome of all the events was reported as not resolved. The causality was unspecified. Additional information has been requested.
Patient inadvertently given Janssen vaccine on 5/17/21. Only later realized patient had already received first dose Moderna  on 4/20/21 (lot number 040B21A, given RD IM). No clinical side effects or issues
Red, swollen upper/forearm, warmth of arm of right arm lasted for 3 days - Swelling and redness started treatment 20 hours after immunization: cool compress - hydrocortisone cream.
This spontaneous report was received from a registered nurse via a company representative and refers to multiple (about seven), unspecified adult patients of unknown age and gender. The patients' medical history, concomitant medications and concurrent conditions were not reported. On unknown dates, about seven adult patients were vaccinated with pediatric doses of RECOMBIVAX HB injection (dose, route of administration, lot# and expiration date were not reported) instead of the adult doses of the vaccines. The medical practice bought pediatric RECOMBIVAX HB accidentally. It could not have been confirmed which dose in the series of RECOMBIVAX HB any of the patients received. No adverse effects were reported. Additional information has been requested.
This is a spontaneous report obtained from a contactable nurse through a Pfizer sales representative. This nurse reported about two patients. This is the second of two reports. A patient of an unspecified age, gender and ethnicity received, on an unspecified date, TRUMENBA single dose. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient developed redness and blotchy swelling at the vaccination site. Clinical outcome was unknown. Follow-up (24Mar2016): Follow-up attempts completed. No further information expected.
pt recv vax 21AUG96 & became pregnant;p/receiving info, pt had a elective therapeutic abortion d/t concern about the child;
Day 1 hour 5: extreme fatigue unable to move. Day 2: fever 100 degrees, exhaustion, flu like. Day 3: low grade fever, exhaustion . Day 4 through Day 22 (on continuing) - exhaustion and severe migraines triggered - unable to function or work with the exception of Day 18-20 - symptoms of exhaustion and dizziness  lighter and migraines only came at night)   All other days significant migraine symptoms requiring all day in bed. Symptoms: facial pain under eye and in cheek bone, severity can then trigger pain around ear throat neck and top shoulder (all right side), nausea , vertigo, motion sickness from walking and being in vehicles and moving head, sensitivity to light sounds and smell. Severity increases when using a device or talking in phone. Much worse on video chats to cut those out.
Startinf 12 hours after vaccine, I experienced a very sore injection site, fever, and body aches. I took Tylenol which lessened symptoms but did not completely make them go away. Symptoms subsided after after 48 hours after vaccine.