chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Site: Bruising at Injection Site-Mild, Additional Details: Pt recieved vaccine at 12pm, was monitored for 15 min and no reaction developed. She noticed burning and swelling of her hands and feet, followed by a full body rash/hives between 11-1:30pm. She took 1 diphenhydramine 25mg followed by 3 separate doses after. She went to urgent care for eval and was given famotidine and prednisone. She was advised to not recieve any further doses of vaccine and proceed to ER if problems.
Bell's palsy; This is a literature report.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "HIV" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: BELL'S PALSY (medically significant), outcome "unknown", described as "Bell's palsy ". The patient underwent the following laboratory tests and procedures: hiv test: +.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the compatible temporal association and the product's known safety profile, the company (Pfizer) considers the event Bell's palsy  is possibly related to COVID-19 vaccine administration. 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.
Patient had syncopal episode shortly after vaccination (while standing up) and fell to the floor.  Patient rested, recovered, and was released to home.
the injection site was sore, red, and swollen; the injection site was sore, red, and swollen; the injection site was sore, red, and swollen; the injection site was sore, red, and swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Apr2021 (Lot number: EP7533) at the age of 44 years as dose 2, single and administered in arm left, administration date 01Apr2021 (Lot number: EP6955) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Alport Syndrome" (unspecified if ongoing), notes: Other medical history: Alport Syndrome, Anxiety; "Anxiety" (unspecified if ongoing), notes: Other medical history: Alport Syndrome, Anxiety; "Known allergies: Latex" (unspecified if ongoing), notes: Known allergies: Latex. Concomitant medication(s) included: LAMICTAL; TRAZODONE; EFFEXOR; FISH OIL; VIT D [VITAMIN D NOS]. The following information was reported: VACCINATION SITE REACTION (non-serious), VACCINATION SITE PAIN (non-serious), INJECTION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious), outcome "recovering" and all described as "the injection site was sore, red, and swollen". Therapeutic measures were not taken as a result of vaccination site reaction, vaccination site pain, injection site erythema, vaccination site swelling.  Additional Information: If other vaccine in four weeks was reported as yes. If covid prior vaccination was reported as no. If covid tested post vaccination was reported as no.   No follow-up attempts are possible. No further information is expected.
11 hr p/vax pt had inc lethargy inc episodes of apnea, bradycardia & 02 desaturation;tx w/supportive therapy;
Elevated bumps around injection site approx 3" x 3". Cellulitis approximately 10 cm L x 5 cm W. Redness immediately surrounding injection site remainder within 48 hours. 5 pm to hosp. Prescription for KEFLEX.
achy; fatigue; chills; This case was reported by a consumer via call center representative and described the occurrence of joint pain in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th June 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 27th June 2019, less than a day after receiving Shingrix, the patient experienced joint pain, fatigue and chills. On an unknown date, the outcome of the joint pain, fatigue and chills were not recovered/not resolved.   It was unknown if the reporter considered the joint pain, fatigue and chills to be related to Shingrix.  Additional details were provided as follows: In night of one day before reporting, the patient began feeling achy in her joints, with fatigue and chills. The reporter gave consent to follow up. There is a discrepancy between the outcome reported in the structured field (not recovered) and the outcome reported in the source document (recovering).
Headache; Chills; Fatigue; Sore muscle; injection site was sore /  injection site still feels a little tender; Injection site was red; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), CHILLS (Chills), FATIGUE (Fatigue), MYALGIA (Sore muscle) and VACCINATION SITE PAIN (injection site was sore /  injection site still feels a little tender) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included CITALOPRAM and CLONAZEPAM for an unknown indication.   On 14-Apr-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 14-Apr-2021, the patient experienced HEADACHE (Headache), CHILLS (Chills), FATIGUE (Fatigue), MYALGIA (Sore muscle), VACCINATION SITE PAIN (injection site was sore /  injection site still feels a little tender) and VACCINATION SITE ERYTHEMA (Injection site was red). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache), CHILLS (Chills), FATIGUE (Fatigue), MYALGIA (Sore muscle), VACCINATION SITE PAIN (injection site was sore /  injection site still feels a little tender) and VACCINATION SITE ERYTHEMA (Injection site was red) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the event was not applicable.
Pt began having nonstop vomiting and diarrhea at 730am the day after vaccination, February 17th. Persisted for over 24 hours so patient came to ER. Pt found to be in a ventricular tachycardia and hypotensive. Pt pale and cool and sts "its hard catching my breath". Pt becoming less responsive and required emergency intervention to stabilize her heart rate and blood pressure. Pt had multiple medications, IV fluids and ultimately emergent cardioversion to stablize heart rhythm.
Right after I got the injection, I felt like my heart immediately started to race and that continued for a couple of hours.   The next afternoon, I got extreme nausea.  I have been nauseated before, but I never had it as bad as this.  Right after this, when I laid down, my heart felt like it was going to go right through my chest it was pounding so hard.  It wasn't as severe after I sat up.  It eventually went away but I considered going to the ER.  I actually called the ER and a nurse was supposed to call me back, but no one did.  I started to feel better and did not go to Urgent Care or the ER, but just rested at home.
PT SAID SHE HAD TERRIBLE VOMITING AND DIARRHEA.  SHE SAID SHE WENT TO THE HOSPITAL AND WAS THERE THREE DAYS RECEIVING FLUIDS AND ANTIBIOTICS.  PT CAME TO PHARMACY AND SAID SHE HAD A ROUGH TIME, BUT WAS NOT SURE IT WAS FROM THE FLU SHOT.
WE RECEIVED A RECALL NOTICE FROM PHARMACY/PFIZER STATING THE VACCINE IS EXPIRED AS OF 9/30/22.
a patient received an expired product Adacel with no adverse event; Initial information was received on 02-Dec-2022 regarding an unsolicited valid non-serious case received from a health care professional.  This case involves 61 years old male patient received an expired product adacel with no adverse event while receiving vaccine diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 02-Dec-2022, the patient received a dose of 0.5 ml suspect diphtheria-2/tetanus/5 ac pertussis vaccine Suspension for injection frequency: total (lot number: C5757AA and expiry date: 21-Jul-2022) via intramuscular route in the left deltoid for .  On 02-Dec-2022 the patient developed a non-serious event of a patient received an expired product adacel with no adverse event (expired product administered) following the administration of diphtheria-2/tetanus/5 ac pertussis vaccine.  It was reported, "Agency reporting that a patient received expired ADACEL. Caller also would like to know does the patient need to wait to be revaccinated if they are on chemotherapy."  Action taken: not applicable.  Outcome: Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Pain - rash at sight of injection continued pain x 3 wks. Nausea, loss of appetite R arm - shingles. L arm Pneumococcal Polysaccharide 23 valent.
Patient's two shots on the right and one shot  on the left arm. the 3 shots were mmr and booster polio and dtap. Her left arm was bruised from the shot and her right arm noticed red mark at  5:30 p.m. When she took the bandaid off. The size of half dollar. On wed after noon 12:45p.m. took her to get her arm checked and they said she is fine.
Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. No concurrent or medical history was reported. On unspecified dates the patients were administered unspecified number of improperly stored doses of MMR II (lot number J006137, expiration date 24-MAY-2015 and lot number K008814, expiration date 19-JUN-2016) (strength, route and dose were unknown). No adverse event was reported. Follow up information has been received from the registered nurse on 27-JUL-2015 concerning a patient of unknown age and gender. On 10-MAR-2015, the patient was vaccinated with an improperly stored dose of MMR II (lot# K008814, expiration date: 19-JUN-2016, strength, route and dose were unknown). This is one of several reports received from the same reporter. Additional information has been requested. Patient's information, products and narrative were updated.
Mom called approx 45 mins post/vax, c/o child had hives all over her face, abdomen & extremities. Had no difficulty breathing, was alert & playing. Mom gave her Benadryl & it made the rash start to clear. (1/12/00 child recovered).
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 13-AUG-2014, the patient was inoculated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 20-FEB-2015, the patient was treated at a hospital for persistent and severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient has been prescribed KEFLEX, ibuprofen, and oxycodone and PEROCET for management of her painful symptoms and chronic pain. On or about 27-MAR-2017, she sought subsequent treatment at a hospital for recurrent shingles treatment with baseline impaired vision that affected her left eye. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested. This spontaneous report as received from a lawyer refers to a female patient of unknown age with routine health maintenance. On 13-AUG-2014 the patient was vaccinated with ZOSTAVAX, unknown for routine health maintenance and prophylaxis. On 20-FEB-2015, 6 months 8 days after onset of therapy the patient experienced herpes zoster, immune system disorder and vaccination failure. On 27-MAR-2017 the patient experienced visual impairment. The outcome of herpes zoster was reported as not recovered/not resolved. The outcome of vaccination failure, visual impairment and immune system disorder is unknown. The reporter considered herpes zoster, visual impairment, immune system disorder and vaccination failure to be related to ZOSTAVAX. {Additional information has been requested. / Additional information is not expected.}
Information has been received from a health professional concerning an employee who about one year ago, in approximately June 2000, was vaccinated with two doses of varicella vaccine. On approximately 06/22/2001, the pt had a negative serum varicella zoster virus antibody titer. Unspecified medical attention was sought. Upon follow-up, it was reported that "there has been some misunderstanding." The health care providers had a general question "about pts that do not convert and produce antibodies once they have been vaccinated." It was further reported, on 07/16/2001, that they "have not experienced any adverse reactions to this date." Further follow-up info received on 08/07/2001 indicated that the employee was not vaccinated at that facility. No further info is available.
1. Arm sore at the site of shot - from the time of shot and ongoing till Sunday, 3/14. (at the time of this report)  2. Headache - from day of shot evening and on going at the time of this report. Headache is on and off and not constant at all times. Only medication taken was Advil 400 mg on 3/13 at 8 pm. 3. Fever - only at bedtime - 3/12 night - 99 F and 3/13 night - 98.9 F. No fever reducer taken.  4. Body ache and tiredness, ongoing.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). An 11-year-old male patient received BNT162b2 (BNT162B2), on 27May2022 at 06:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 11 years intramuscular for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: unknown; Route of administration: unknown), for Covid-19 Immunization; Bnt162b2 (DOSE 2, SINGLE; Lot number: unknown; Route of administration: unknown), for COVID-19 Immunization. The following information was reported: MIGRAINE (non-serious) with onset 27May2022 at 22:00, outcome "recovered" (May2022), described as "Child got a migraine about 16 hours after receiving his booster (3rd dose) of the vaccine.". Therapeutic measures were taken as a result of migraine. Additional information: Child got a migraine about 16 hours after receiving his booster (3rd dose) of the vaccine. He took Tylenol and felt better after about an hour. The previous doses did not result in a headache. The patient did not test positive for COVID-19 prior or since having had the vaccine. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Headaches, tremors in the hand, fever of 103 the night of the vaccine, red bump at vaccine site (pt. describes not any worse bump then with other vaccines). Dulled vision and slight fatigue (more then normal).
Altered sensation in throat.  No other sx.  Given Benadryl 25 mg with improvement.
Fever started 6:00 pm 6/29/01 zero actual temperature taken per mom.  Tylenol given. Fever over weekend, mom states daughter is irrrtable and uncomfortable and complains of sore throat.  Motrin givens relief.  Encouaged PMP visit ASAP
Information has been received from a pharmacist via a company representative referring got a 60 years old female patient. The patient's medical history, concurrent condition and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX 19400 PFU (dose, lot #, expiration date and route not reported). On an unknown date, the patient experienced tenderness and swelling at the injection site after administration of ZOSTAVAX. The patient sought medical attention. It was unknown if treatment was given for the events. The outcome of the events was unknown. The causality between ZOSTAVAX and the events was not provided. This is one of two reports received from the same reporter. Additional information is not expected as no consent to contact the physician.
Pt complain of feeling light headed and clammy shortly after the shot. She did not say anything until 10-15 min after shot. I had her rest for awhile. When she left she looked well but said her hands and feet felt a little cold. But she said felt okay overall.
Narrative: COVID infections following completion of COVID vaccine series 03/08/2021 COVID vaccine dose #1 03/30/21 COVID vaccine dose #2 04/26/2021 Pt presents to ED reporting suffering abrasions on left side of body from motorcycle accident; complains of right elbow and right upper leg pain; denies head injury and SOB; treated with toradol; Tdap administered; discharged with naproxen, methocarbamol, bacitracin 07/22/21 Pt reports exposure to COVID positive wife and requests COVID test; reports cough, nasal congestion, and postnasal drip x1 day; COVID POSITIVE 07/23/21 Pt reports chills, cough, fatigue, fever, muscle pain , runny nose, sore throat; rx given for acetaminophen, albuterol, DM/guaifenesin, sodium chloride nasal spray, lozenges 07/26/21 Pt reports loss of taste/smell, productive cough, fatigue, loss of taste/smell, runny nose 08/03/21 COVID POSITVE
Pfizer-BioNTech COVID- 19 Vaccine EUA: Vaccine recipient became anxious during vaccination with no other complaints mentioned. EMS evaluated her and she took her own diphenhydramine. She refused additional treatment. She left the clinic unassisted.
heart rate going fast about 105 for about an hour; This spontaneous case was reported by a nurse and describes the occurrence of HEART RATE INCREASED (heart rate going fast about 105 for about an hour) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced HEART RATE INCREASED (heart rate going fast about 105 for about an hour). At the time of the report, HEART RATE INCREASED (heart rate going fast about 105 for about an hour) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Feb-2021, Heart rate: 105 (High) 105.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter. No treatment information was provided.
Finger, hand, and forearm pain, numbness and tingling. Some improvement with immune support supplements and regular infrared sauna treatment.
On 5/2 I woke up to a large red circle inside of my armpit that burned on the same side of my vaccination. My lymph nodes were extra red and itchy.  I tried icing and taking benadryl that day and resting but later in the day presented with hives that day.  I didn't sleep that night due to the itching and pain in my nodes. I saw a telehealth Dr on Monday 5/3 who advised me to visit an immediate care or ER due to concerns of past DVT. I proceeded to Er my vitals were taken, monitored pulse and connected to monitor for heart no other tests.  Dr determination based on history and presentation that the reaction was a latent reaction to the vaccine. I was given 60 mgs of prednisone at the hospital, 60 day after and have been reduced to 40 until Friday 5/7. I am also to take up to 3 benadryl as needed per day for itching. I have follow up with my pcp on Monday 5/10.
Pt had flu shot at school flu clinic. At PM (bedtime) pt c/o lips feeling "silky" parent advised to go to bed. When pt awoke in A.M. parent advised lips swollen above nose with 8 blisters on top lip, 4 on bottom lip, blisters inside mouth, and skin "blotchy". Parent gave pt BENADRYL - 11-1-14 pt started vomiting all weekend taken to PCP 11-3-14. PCP uncertain of reaction but advised parent to notify HD. Culture done on blisters (dried) 11-3-14 at PCP per mom. 11/24/14 - cultures were not obtained.
Flare up of the arm; felt bad; 7 patients late second dose of Shingrix over 6 months, with one of those patient being due today; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced rash, feeling bad and incomplete course of vaccination. On an unknown date, the outcome of the rash, feeling bad and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the rash and feeling bad to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient flare up of the arm and felt bad after the 1st dose of Shingrix and late for second dose of Shingrix over 6 months, which led to incomplete course of vaccination.  HCP unable to provide full patient details. The reporter did not consented to follow up.  This was 1 of 7 cases, reported by the same reported.